Apparatus and method for performing an anastomosis

ABSTRACT

An anastomosis is performed using a flexible mounting structure mounted on the outside of at least one vessel. Fasteners extend through the vessel and are bent towards the incision to attach the flexible mounting structure to the vessel in a manner that controls the edge of the vessel adjacent to the incision. The mounting structures are oriented on each vessel so fasteners on one mounting structure interdigitate with fasteners on the other mounting structure at the location of contact between the vessels when the two vessels are brought together. This creates two complementary sinusoidal-shaped vessel edges with peaks of one edge being accommodated in the valleys of the other edge. The peak-to-valley orientation forms a sinusoidal-shaped joint which is leak free. The fasteners are spaced so proper pressure is applied to the tissue to promote healing without leaking. Furthermore, the fasteners are sized and shaped to properly engage the tissue and bend in a desired manner. Methods and tools for carrying out the anastomosis according to the invention are also disclosed. Methods for forming the fastener and the tines having the proper characteristics are disclosed. An absorbable ring-shaped stent is also disclosed.

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims benefit of provisional application SerialNo. 60/150,033 filed Aug. 20, 1999. The present application is alsobased on continuation-in-part of U.S. application Ser. No. 09/200,796,filed on Nov. 27, 1998 which is presently pending and which is adivisional application of Ser. No. 08/714,615, filed on Sep. 16, 1996,now U.S. Pat. No. 5,868,763.

TECHNICAL FIELD OF THE INVENTION

[0002] The present invention relates to the general art of surgery, andto the particular field of anastomosis.

BACKGROUND OF THE INVENTION

[0003] In the United States, there are currently as many as 300,000coronary artery bypass graft (CABG) procedures performed on patientsannually. Each of these procedures may include one or more graft vesselswhich are hand sutured. Until recently, coronary artery bypassprocedures have been performed with the patient on cardiopulmonarybypass whereby the heart is stopped with cardioplegia and the surgery isperformed on an exposed, stationary heart.

[0004] The vast majority of CABG procedures currently performed areaccomplished by opening the chest wall to gain access to the coronaryvessels. Through the use of heart lung bypass machines and a drug toprotect the heart muscle, the heart is stopped and remains still duringthe procedure. In this setting, the surgeon has ample time and access tothe vessels to manipulate hand suturing instruments such as forceps,needle holders and retractors.

[0005] However, with increasing costs of hospital stays and increasedawareness by patients of other minimally invasive surgical procedures,interest in developing a minimally invasive CABG procedure isincreasing. Hospitals need to reduce costs of procedures and patientswould like less post-operative pain and speedier recovery times.

[0006] In the past, two significant developments in technology played amajor role in advancing the whole area of cardiac surgery. Theheart-lung machine was invented in the 1950's and underwent significantimprovement in design to become a reliable clinical device in the1960's. The heat-lung machine allows the surgeon to take the heart outof the blood circulation system to work on it in isolation.

[0007] The second major development was in myocardial protection. Whenthe heart is isolated from the circulation, it is no longer perfused.After twenty to thirty minutes of ischemia, irreparable damage may occurand no matter how good the repair, the heart function may be inadequateto allow the patient to survive. The development of cardioplegia, asolution which is generally cold and high in potassium, changedeverything. This development occurred in the 1970's. Cardioplegia allowsvery satisfactory protection of the heart so the surgeon can perform anunhurried repair and still expect the heart to work afterward.

[0008] An unforeseen consequence of these technology developments wasthe decline in interest in technology to facilitate and expedite heartsurgery. When speed of the surgery was of utmost importance, manydevelopments were proposed to speed surgery. Therefore, while the art inthe 1960's and 1970's contained numerous examples of devices intended toexpedite heart-related surgery, the incidence of such devices declinedafter about 1970.

[0009] With an increased incentive to reduce costs, there is a renewedinterest in expediting cardiothoracic procedures. A few pioneeringsurgeons are now performing minimally invasive procedures in which thecoronary artery bypass is performed through a small incision in thechest wall. There are some surgeons that believe that the best way toperform a minimally invasive coronary artery bypass procedure is toperform the procedure on a beating heart, i.e., without heart-lungbypass and cardioplegia. This minimizes the time it takes to perform theprocedure, reduces the cost of the operation by eliminating the heartlung bypass machine and reduces recovery time.

[0010] In the case of minimally invasive procedures on a beating heart,the surgeon starts by making a mini-thoracotomy between the fourth andfifth ribs and, sometimes, removing the sternal cartilage between thefourth or fifth rib and the sternum. The space between the fourth andfifth ribs is then spread to gain access to the internal mammary artery(IMA) which is dissected from the wall of the chest. After dissection,it is used as the blood supply graft to the left anterior descendingartery of the heart (LAD). The pericardium and the heart are locatedbelow the IMA. The pericardium is opened exposing the heart. At thispoint, the LAD may be dissected from the fissure of the heart andsuspended with soft ligatures to isolate the artery from the beatingheart. A small arteriotomy is performed in the LAD and the graft IMA issutured to the LAD.

[0011] Heretofore, access to the cardiac vessels is gained for thisprocedure by sawing the sternum in half and separating the chest wall.Although this procedure is currently well perfected, the patient suffersintense pain and generally requires a long recovery period.

[0012] Until recently all bypass graft procedures have been performed byhand suturing tiny vessels together with extremely fine sutures undermagnification. The skills and instruments required to sew extremely thinfragile vessel walls together have been perfected over the last twentyyears and are well known to the surgical community that performs theseprocedures.

[0013] In the “open chest” surgical setting, the surgeon has adequateaccess and vision of the surgical site to manipulate the anatomy andinstruments. However, in minimally invasive procedures, this access isoften severely restricted thereby inhibiting such procedures.

[0014] Furthermore, the interest in less invasive surgical approaches ispromoting concomitant interest in many areas that were abandoned longago, including coronary fastening and valve replacement. In view of theabove-discussed developments, the inventors have thus identified a needfor a device and a method to perform CABG surgery on a beating heart.

[0015] Some surgeons are attempting minimally invasive CABG proceduresusing femoral artery bypass access rather than opening the chest forbypass via the aorta. However, since use of cardioplegia requiresadditional support and expense during the anastomosis procedure, theinventors believe that it is best to attempt to fasten the anastomosiswhile the heart is beating. However, this procedure when performed witha hand suturing technique is very imprecise due to the translation ofmovement from the beating heart to the suspended artery. This may causeimprecise placement of the suture needles. Imprecise placement of thesutures may cause a distortion of the anastomosis which may causestenosis at the junction.

[0016] The sutures used for this procedure are extremely fine (0.001″ indiameter) and are placed less than 1 mm apart. As one can imagine it isdifficult enough to place suture needles the size of a small eyelashinto a vessel wall with placement accuracy of better than 1 mm; yet toaccomplish this feat of precision on a moving target is even moredifficult. To make matters worse the site is often obscured by bloodbecause the heart has not been stopped.

[0017] Therefore, there is a need for a means and method which permitsthe forming of a precise anastomosis without requiring the stopping of abeating heart. Still further, there is a need for performing such ananastomosis in a minimally invasive manner.

[0018] The current method of hand suturing has the several drawbacks,including the following.

[0019] On a beating heart it may be difficult to place the sutures withthe position precision required. In a beating heart procedure thesurgeon can attempt to minimize the deleterious effects of the movementby using suspension or retraction techniques. However, it is impossibleto isolate all movement of the vessel during an anastomosis procedure.

[0020] Methods that attempt to stabilize and isolate an artery from themovement of the beating heart may damage the vessel or cause myocardialinjury (MI).

[0021] In addition to the problem of accurately placing sutures, anincision through the artery wall to open the artery must be made. This,too, is a delicate procedure even on a still heart because the incisionmust be of a precise length. It is also critical to not penetrate theback wall or side wall of the vessel which will lead to complications.The placement of the initial incision is of paramount importance. Thesurgeon must pick a suitable location free from calcium deposits, fatand side branches.

[0022] Without cardioplegia, blood flow to the heart muscle must also beprovided while the heart is beating; therefore, after the initialarteriotomy the surgical field is very bloody and obscured.

[0023] Access to the heart vessels other than the LAD will be extremelydifficult with minimally invasive hand suturing due to the anatomicallocation of the posterior wall of the heart.

[0024] Although minimally invasive CABG procedures are taking place nowwith sutured anastomosis they require superlative skills and aretherefore not widely practiced.

[0025] One of the most vexing problems is that of adequate access. Theprocedure takes place through an access site created between two ribs.The ribs cannot be spread too far without risk of breaking and the heartlies deep within the chest. The access is through a small, long, darktunnel. The surgeon must then manipulate tools down this tunnel withoutobscuring his or her vision.

[0026] If special tools are constructed to allow the surgeon to holdsuture needles on the end of a long instrument, the added length of thetool only amplifies any inaccurate manipulation. The same is true forany special suturing devices.

[0027] If the sutures are not correctly placed in the vessel walls,bunching or leaks may occur. In the minimally invasive procedure this isdisastrous usually resulting in the conversion to an open chestprocedure to correct the mistake. Any rough handling of the vessel wallsis detrimental as inflammation can cause further postoperativecomplications.

[0028] An anastomosis must be leak tight to prevent exsanguination.Therefore, any improvement over sutures must provide a leak free seal ina very confined space, yet should provide proper flow areas in thevessel after healing is complete.

[0029] As can be understood from the above discussion, it is necessaryto find a way to control the beating heart-induced movement of thevessel while performing the anastomosis in such a way that still allowsfor exact placement of a fastening means during a beating heartanastomosis procedure.

[0030] While the art contains disclosures of several devices that areused to join blood vessels, these devices are primarily directed to anend-to-end anastomosis, and thus are inadequate for CABG procedures.Furthermore, the techniques taught in the prior art often require thevessels to be severely deformed during the procedure. The deformationmay be required to fit the vessels together or to fit a vessel to ananchoring device. One cannot just slit the tissue and pull it through aring to anchor it on a flange. Pulling or stretching the vessel wallsproduces a very unpleasant and unexpected result. Vessel walls are madeof tissue fibers that run in the radial direction in one layer and thelongitudinal direction in another layer. In addition, the elasticity ofthe tissue fibers in the longitudinal direction is greater than thosethat run radially. Therefore, the tissue will not stretch as easily inthe radial or circumferential direction and results in a narrowing orrestriction when pulled or stretched in the prior art devices. Vesselwalls also have a layer of smooth muscle cells that can spasm if treatedharshly. Such manhandling will result in restrictions and stenoticjunctions because the vessel walls will react poorly to being treated insuch a rough manner and the stretching of the vessel wall will telegraphup the vessel wall due to the high radial stiffness of the vesselstructure causing restrictions and spasms in the vessel wall. The priorart fails to teach that the vessels are living tissue and must not bemade to conform to rigid fitting-like shapes. Therefore, there is a needfor an anastomotic technique that permits handling of blood vessels in amanner that is not likely to cause those blood vessels to react in anundesirable manner

[0031] Additionally, the prior art fails to teach methods of ensuringhemostasis so there is no leakage under pressure. It is noted thatmechanical devices used to join blood vessels are extremely difficult toseal. Prior art devices are generally directed to accomplishinghemostasis through excessive clamping forces between clamping surfacesor stretching over over-sized fittings.

[0032] In order to effect good healing, healthy vessel walls must bebrought into intimate approximation. This intimate approximation is nowaccomplished using sutures. A vascular surgeon is taught how to sutureby bringing the vessel edges together with just the right knottightness. A knot that is too loose may cause the wound to leak and havetrouble healing causing excessive scar tissue to form. A knot that istoo tight may tear through the delicate tissue at the suture holecausing leaks. The key is to bring the edges together with just theright amount of intimate approximation without excessive compression.

[0033] It is further noted that the junctions taught in the prior artare not anatomically correct both for blood flow and for healing. A wellmade anastomotic junction is not made in a single plane and shouldaccurately follow blood vessel geometry. The junction is more of asaddle shape and the cross section is not necessarily a circle. Thejunction where the vessel units join is not a constant cross sectionangle but an angle that varies continuously throughout with respect toany linear reference. In addition, the length of the junction should bemany times the width of the opening in order to ensure a low blood flowpressure gradient in the junction and to establish a proper flow area.In fact the best results are obtained if the confluence area is actuallyoversized. The prior art junctions do not account for such flowcharacteristics and parameters and are thus deficient. Therefore, thereis a need for an anastomotic technique which can establish proper flowcharacteristics and parameters and that accurately preserves bloodvessel geometry, specifically the plural planar nature in which thejunction occurs. Furthermore, most anastomoses are made between vesselsthat are not similar in size. It is therefore necessary to provide ameans and method which allow for the accommodation and joining ofdissimilarly sized vessels.

[0034] In addition, the inventors have found through post surgicalfollow-up that the supply vessels grow in diameter to accommodate theirnew role in providing oxygenated blood to the heart; therefore, there isa need to provide an oversized junction to accommodate any increase inthe dimension of the graft vessel size. With a rigid ring that has asingular circular cross section of the graft, the fitting does not allowthe vessel to provide this increase in flow as the vessels expand tomeet the needs of the heart muscle. Still further, the inside lining ofthe vessel walls (intima) should make contact with each other to haveproper healing. The walls of the vessels must come together with justthe right amount of approximation to promote good healing. If theincised edges are too far apart scarring will occur causingrestrictions. The walls cannot be compressed between two hard surfaceswhich will damage the vessels. The prior art teaches plumbing-likefittings clamped onto vascular structures. However, clamping andcompressing the vessel walls too tightly may cause necrosis of thevessel between the clamps. If necrosis occurs the dead tissue willbecome weak and most likely cause a failure of the joint. Still furthersuch rings and tubes used to clamp vessels together do not follow thecorrect anatomical contours to create an unrestricted anastomosis.Failing to account for the way healing of this type of junction occursand not accounting for the actual situation may cause a poor result. Asuture technique has the advantage of having the surgeon makingon-the-fly decisions to add an extra suture if needed to stop a leak inthe anastomosis. In a mechanical minimally invasive system it will notbe possible to put an “extra suture throw” in so the system must providea way to assure complete hemostasis. Being a mechanical system theapproximation will not be 100% perfect. And since the design errs on theside of not over-compressing the tissue there may be very small areasthat may present a leak between the edges of the vessel walls.Accordingly healing with prior art techniques using mechanical joiningmeans is not as efficient as it could be. Therefore, there is a need foran anastomotic technique that accounts for the way healing actuallyoccurs and provides proper structural support during the healingprocess.

[0035] When vascular integrity is interrupted, the body quickly reactsto reestablish hemostasis. Circulating blood platelets are quicklymobilized to the injury site and initiate and support the coagulationsequence that leads to the formation of a fibrin plug at the site ofinjury. Large breaks in vessel walls which are under pressure cannot beeffectively sealed by platelets and fibrin without a substrate tocollect on. It is critical that the junction of an anastomosis bring twohealthy vessel surfaces in close approximation to provide an optimalregion for vessel repair and healing, minimizing the distance betweenhealthy endothelial cells on either side of the junction. This allowsfor the natural control processes which prevent platelet aggregationfrom extending beyond the area of injury. A more detailed description ofthe clot limiting process and the healing process can be found invarious reference texts, such as “Coagulation: The Essentials”, byFischbach, David P and Fogdall, Richard P, published by Williams andWilkins of Baltimore in 1981, the disclosure of Chapter 1 thereof beingincorporated herein by reference.

[0036] Still further, some vessels are located or sized in a manner thatmakes placing elements thereon difficult. In such a case, the fewerelements used to perform an anastomosis the better. Therefore, there isa need for a means and a method for performing an anastomosis that canbe effected without the need of a hemostatic medium.

[0037] Many times, when a CABG operation is undertaken, the patient hasmultiple clogged arteries. At the present time, the average number ofgrafts is 3.5 per operation. When multiple grafts are performed, thereis sometimes the opportunity to use an existing or newly added supplyvessel or conduit for more than one bypass graft. This is known as ajump graft whereby the conduit at the distal end thereof is terminatedin a side-to-side anastomosis first, with an additional length ofconduit left beyond the first junction. Then, an end of the conduit isterminated in an end-to-end junction. This saves time and resources andmay be necessary if only short sections or a limited amount of hostgraft material is available.

[0038] At the present time, existing means and methods of performing ananastomosis do not permit the formation of multiple anastomotic sites ona single graft vessel at both proximal and distal ends. Thus a surgeonwill have to use multiple tools to perform multiple anastomoses. Thiswill be either impossible or very expensive.

[0039] Therefore, there is a need for a means and a method forperforming an anastomosis which will lend itself to efficient andcost-effective multiple by-pass techniques. There is also a need for ameans and a method for performing an anastomosis which will lend itselfto efficient and cost-effective jump graft techniques.

[0040] As discussed above, performing a sutured anastomosis in aminimally invasive manner while the patient's heart is beating requiresan extremely high degree of skill and dexterity. Any instrument used insuch a procedure must therefore be as easy and efficient to use aspossible whereby a surgeon can focus most of his attention on theanastomosis site. The instrument should thus reflect the above-discussedneeds as well. Still further, any instrument used in such a proceduremust be amenable to efficient manufacture.

[0041] The parent applications, incorporated herein by reference andwhich will be referred to as the parent disclosures, disclose anapparatus and method for forming a precise and anatomically accurateanastomosis on a patient without requiring the patient's heart to bestopped. The means of the parent disclosures includes an instrument thatprecisely places fasteners on the outside surface of a blood vessel in aposition to cause the anastomosis to have the proper flow area and toaccurately reflect the geometry of the junction. The means of the parentdisclosures further position the inside edges of the two incised bloodvessels forming the anastomosis in abutting contact with each otherwhereby proper healing is promoted.

[0042] The present invention amplifies the edge-positioning feature ofthe parent disclosures so the joint formed is leak free and isanatomically accurate whereby proper healing is promoted. This is stillachieved in a minimally invasive surgery situation where proper controlof the incised vessels can be difficult to achieve, especially when thepatient's heart is beating during the procedure, and does not require ahemostatic medium.

[0043] Still further, the accurate and precise control of the vesselwalls should be carried out in the most efficient manner in order tomost efficiently complete the procedure.

[0044] Therefore, there is a need for a means and a method forperforming an anastomosis in a minimally invasive manner that fulfillsthe objectives set forth in the parent disclosures and does so in anefficient manner that forms an accurate and precise joint that is asleak free as possible, even without a hemostatic medium.

[0045] As can be understood from the above disclosures, the targets andelements used in performing an anastomosis are often very small. Stillfurther, the procedure will be performed in a very difficult sight area.These two situations combine to make proper alignment of the vesselsextremely difficult. However, proper alignment is a necessity.

[0046] Therefore, there is a need for a means and a method for properlyaligning two vessels during a minimally invasive surgical procedure.

[0047] As discussed above and in the parent disclosures, the joint of ananastomosis is formed when the two malleable ring-shaped stents arebrought together and attached. An important factor for success for amechanical anastomotic device is how the tissue is approximated toprevent leaks and to allow the tissue to heal without inflammation orthrombosis, which can lead to a thickening or stenosis at the joint.Thus, the inventors have found that tissue compression at the joint siteis important but has not been considered in the prior art. As notedabove, it is important not to “over compress” the joint, yet at the sametime, the joint must not leak more than a couple of milliliters perminute under physiological blood pressures to allow the natural clottingprocess to seal any small leaks quickly, after the joint has beenformed.

[0048] These conflicting considerations present a significant problem.While it might appear to be best to clamp the joint tightly together toprevent leaks, too much force clamping the tissue is not desirablebecause the tissue healing response is altered by crushing forces. Astissue is crushed or “over compressed”, certain chemical activators arereleased which can cause blood platelets to aggregate. In addition,injured tissue cells expose a phospholipid surface upon which theclotting cascade coagulation factors interact to form a clot. Anotherwise patent anastomosis can be occluded due to an excessive releaseof clotting factors resulting from a compression injury. There arenatural inhibitors to platelet aggregation (prostacyclin) and clotformation, produced when an activated platelet comes in contact withnormal vessel wall. Therefore it is important to design a joint that inaddition to being virtually leak free, will provide anatraumatic-sealing configuration and present normal tissue and minimalforeign material to the interior of the blood vessel.

[0049] The parent disclosures disclose malleable mounting structureshaving fastening elements thereon for attaching the mounting structuresto a vessel. These fastening elements include a body having one endattached to a ring and a tip on the other end. The fasteners are formedby forcing them against arcuate grooves in a manner that is intended toturn the fastener on itself in the manner of a staple. However, theinventors have found that it is important to control the fastener suchthat when it is engaged with the arcuate groove, it will deform in thedesired manner rather than simply fold or crumple.

[0050] Therefore, there is a need for a means for controlling theformation of the fastening means disclosed in the parent disclosures toensure that they will bend in the desired manner.

[0051] In the parent disclosures a joint was established using theconcepts of fasteners or tines, mounted on a malleable ring-shapedstents. These tines are used to bring the internal layers of the vesselwall to the surface of the malleable ring-shaped stents. In addition,several of the embodiments have employed a hemostatic media externallyto promote sealing of any blood at the joint. The inventors havediscovered that by staggering the tines on one ring relative to anotherring, the tines form the tissue between each other. This interdigitationof the tines reduces leakage to an absolute minimum. An acceptable leakrate is less than 2 ml/min at 200 mm/Hg. However, staggering the tinesis not the only factor that contributes to stopping joint leakage, theshape and surface quality of the tines itself also contributes toreducing the leak rate at the joint. The inventors have also discoveredthe known manufacturing processes produce 90° sharp edges. 90° sharpedges tend to cut through tissue allowing relatively large pathways inwhich blood leaks through the tine holes. This is mainly due to EDM(electrode discharge machine) or chemical etching methods, which producea dead sharp edge. Both processes orientate themselves perpendicular tothe material that will be machined leaving the sharp edges as abyproduct. Traditional secondary operations used to remove the sharpnessfrom the elements include electropolishing and mechanical deburring.Electropolishing removes extremely small amounts of material from theentire part at the same time. The object to be electropolished issubmersed into a chemical bath that is electrically charged therebyuniformly removing small amounts of material on the outer surface of thepart. If applied to the malleable stents of interest, it would round thefasteners in an acceptable manner but the tips of the tines would becomedull and, unable to pierce the vessel wall and the malleable stent wouldbecome too weak from the amount of material which has been removed.Also, the malleable stent would not be perfectly planar due to theinconsistent nature of electropolishing. The deburring process alsoremoves a small amount of material from a part. There are different waysto deburr. One way is a batch process in which many parts are loadedinto a rotating container similar to a clothes dryer. A granularabrasive media is added with the parts and the container begins to spin.The media slowly removes any burrs and rounds the edges of the parts.The problem with this process is the parts must be stiff enough towithstand the tumbling effect, and not be bent or deformed by theprocess. Also parts such as those of interest may tangle with each otherwhen removed making it difficult to separate the parts without damagethereto. Furthermore this type of deburring is not a precisionoperation. Thus, for the product of interest, some tines may be sharperor thinner than others thereby adversely affecting not only the abilityof the joint to be leak-free but also compromising the deployment of themalleable stent on the vessel. Another method of deburring is a manualoperation with each malleable stent being individually blasted with aprecision instrument. However, the parts may be inconsistent.

[0052] Thus, there is a need for a process that can be used to formmalleable stents useful in the anastomosis process of interest and whichcan uniformly remove sharp edges on tines without dulling the tine tipand without removing any material from the malleable body and yet stillbe cost effective to manufacture in volume production.

[0053] Still further, it is often helpful if any artificial elementsplaced in a patient during a procedure such as the anastomosis ofinterest in this disclosure be absorbed after the healing process iscomplete. The anastomotic joint that has been disclosed in parentdisclosures has a continuous malleable ring-shaped stent that willremain intact inside the body for the life of the patient whilemaintaining a predetermined opening. The inventors have observed thatsometimes under high demand conditions, graft vessels will grow to makeup for an increase in flow demand. While the anastomotic joint isusually created oversized to accommodate this demand it is difficult topredict the exact size that will be needed years ahead. Therefore, thereis a need for an anastomosis system that uses elements that can beabsorbed by the patient's body after the healing process is complete.

OBJECTS OF THE INVENTION

[0054] It is a main object of the present invention to provide anapparatus and method of performing an anastomosis without stopping thepatient's heart.

[0055] It is also an object of the present invention to provide ananastomosis joint that is leak free and accurate.

[0056] It is another object of the present invention to provide anapparatus and method of performing an anastomosis without stopping thepatient's heart in a minimally invasive manner.

[0057] It is another object of the present invention to provide anapparatus and method of performing an anastomosis without stopping thepatient's heart in a minimally invasive manner in which the bloodvessels are joined together in such a way as to most efficiently promotehealing.

[0058] It is another object of the present invention to provide anapparatus and method of performing an anastomosis without stopping thepatient's heart in a minimally invasive manner in which the bloodvessels are joined together without squeezing, compressing or otherwisemanhandling them.

[0059] It is another object of the present invention to provide a methodand apparatus to stabilize a vessel while performing an anastomoticprocedure.

[0060] It is another object of the present invention to provide anapparatus and method of performing an anastomosis without stopping thepatient's heart in a minimally invasive manner in which the bloodvessels are joined together to form a confluence area that accuratelyaccounts for flow characteristics and flow parameters.

[0061] It is another object of the present invention to provide anapparatus and method of performing an anastomosis without stopping thepatient's heart in a minimally invasive manner in which blood vesselscan be joined together in a side-to-side configuration.

[0062] It is another object of the present invention to provide anapparatus and method of performing an anastomosis without stopping thepatient's heart in a minimally invasive manner in which blood vesselscan be joined together in an-end-to-side configuration.

[0063] It is another object of the present invention to provide anapparatus and method of performing an anastomosis without stopping thepatient's heart in a minimally invasive manner in which blood vesselscan be joined together to form a junction that is anatomically correctand accurately reflects blood vessel geometry at the junction.

[0064] It is another object of the present invention to reduce tissueinflammation and necrosis due to mishandling and over compression.

[0065] It is another object of the present invention to provide ananastomotic stapling device that provides blood flow to the heart whilemaking the anastomosis.

[0066] It is another object of the present invention to provide ananastomotic apparatus and method which can join dissimilarly sizedvessels.

[0067] It is another object of the present invention to provide ananastomotic apparatus and method which will accommodate joining vesselwalls at a junction angle that varies with respect to a reference line.

[0068] It is another object of the present invention to provide ananastomotic apparatus and method which can effect a junction without ahemostatic medium.

[0069] It is another object of the present invention to provide ananastomotic apparatus and method which can be used in proximal junctionsand in multiple anastomotic sites on the same vessel.

[0070] It is another object of the present invention to provide ananastomotic apparatus and a method for performing an anastomosis whichwill lend itself to efficient and cost-effective multiple by-passtechniques.

[0071] It is another object of the present invention to provide ananastomotic apparatus and method for performing an anastomosis whichwill lend itself to efficient and cost-effective jump graft techniques.

[0072] It is another object of the present invention to provide ananastomotic apparatus and method which is especially well suited for alltypes of blood vessel anastomosis procedures and techniques, such as,but not limited to, proximal, side-to-side, end-to-side, jump grafts aswell as others that will occur to those skilled in the art based on theteaching of the present disclosure.

[0073] It is another object of the present invention to provide ananastomotic apparatus and method in which the two vessels involved inthe procedure are properly and accurately aligned in an expeditiousmanner.

[0074] It is another object of the present invention to provide ananastomotic apparatus and method for ensuring the proper formation offasteners used to attach anastomosis elements to vessels.

[0075] It is another object of the present invention to provide ahemostatic joint by the interdigitation of the tines.

[0076] It is another object of the present invention to provide anadjustable hemostatic joint.

[0077] It is another object of the present invention to provide ahemostatic joint that promotes tissue healing.

[0078] It is another object of the present invention to provide ahemostatic joint that does not crush tissue.

[0079] It is another object of the present invention to provide joiningapparatus with an asymmetrical design of the tines.

[0080] It is another object of the present invention to provide ahemostatic joint with an atraumatic-sealing configuration.

[0081] It is another object of the present invention to provide ahemostatic joint by using the vessel as a compliant sealing media.

[0082] It is another object of the present invention to provide ahemostatic joint by varying the spacing of the tines based on the wallthickness at the vessel to provide optimum sealing compression.

[0083] It is another object of the present invention to provide ahemostatic joint having a ring-shaped stent for forming the joint inwhich the tines on the stent enter the outside wall of a vessel and turnthe tissue of the vessel inward and up onto the stent.

[0084] It is another object of the present invention to provide a devicethat will deliver a hemostatic malleable ring-shaped stent to a vessel.

[0085] It is another object of the present invention to provide a devicethat will deliver a hemostatic malleable ring-shaped stent in adisposable cartridge.

[0086] It is another object of the present invention to provide a devicethat will provide proper guidance of the tines to enable properformation of the tines on the tissue.

[0087] It is another object of the present invention to provide a devicethat will deploy a secondary anvil to crimp the tips of the tines;thereby locking on the tissue.

[0088] It is another object of the present invention to provide a devicethat will deploy a cutter to open the vessel wall within a ring to apredetermined size.

[0089] It is another object of the present invention to provide aring-shaped stent that will change shape after installation on a vessel.

[0090] It is another object of the present invention to provide a devicethat is compact in size and allows the surgeon to position the tool withone hand.

[0091] It is another object of the present invention to provide a devicethat is ergonomic and allows adequate visualization to the surgicalsite.

[0092] It is another object of the present invention to provide a devicefor use with malleable ring-shaped stents used for tissue joinder thatwill approximate the malleable stents.

[0093] It is another object of the present invention to provide a devicethat will approximate the malleable stents and can be remotelyactivated.

[0094] It is another object of the present invention to provide a devicethat will join where joint compliance is provided by a docking leg.

[0095] It is another object of the present invention to provide a devicethat will join with joint compliance in the joining device.

[0096] It is another object of the present invention to provide a devicethat will approximate the malleable ring-shaped stents with a lowprofile end effector.

[0097] It is another object of the present invention to provide a devicethat will join the malleable stents.

[0098] It is another object of the present invention to provide a devicethat will permanently join the malleable stents and can be activatedremotely.

[0099] It is another object of the present invention to provide anapparatus for joining the malleable stents that will deform onering-shaped stent to fit on another.

[0100] It is another object of the present invention to provide anapparatus for joining the malleable stents with pre-tied suture loop.

[0101] It is another object of the present invention to provide anapparatus for joining the malleable stents with an elastomeric ring.

[0102] It is another object of the present invention to provide anapparatus for joining the malleable stents with a v-shaped spring clip.

[0103] It is another object of the present invention to provide anapparatus for joining the malleable stents with a c-shaped clip thatwill deform.

[0104] It is another object of the present invention to provide anapparatus for joining the malleable stents with a post and holearrangement.

[0105] It is another object of the present invention to provide anapparatus for guiding the malleable stents together with a guide suture.

[0106] It is another object of the present invention to provide a methodof manufacturing an anastomotic device with a chemical etch process.

[0107] It is another object of the present invention to provide a methodof manufacturing an anastomotic device with chemical double etch processto produce areas of different thickness and edge properties.

[0108] It is another object of the present invention to provide a methodof manufacturing an anastomotic device in a cost-efficient batchoperation.

[0109] It is another object of the present invention to provide a methodof manufacturing an anastomotic device in a cost-efficient batchoperation with registration features for a secondary operation.

[0110] It is another object of the present invention to provide a methodof manufacturing an anastomotic device with tines that have a sharppointed tip with rounded edges.

[0111] It is another object of the present invention to provide ananastomotic apparatus and method in which the elements can be absorbedinto the patient's body after the healing process is complete.

[0112] It is another object of the present invention to provide ananastomotic device with absorbable polymer sections.

[0113] It is another object of the present invention to provide ananastomotic device with expandable sections.

[0114] It is another object of the present invention to provide anabsorbable polymer and stainless steel anastomotic device.

[0115] It is another object of the present invention to provide anabsorbable polymer and titanium anastomotic device.

[0116] It is another object of the present invention to provide ananastomotic device that will change size based on the increased demandof blood flow to the heart.

SUMMARY OF THE INVENTION

[0117] These and other objects are achieved by the minimally invasivedevices and methods disclosed in the parent applications which isfurther improved by including an apparatus and method for controllingthe edges of the vessel wall to define an accurate and leak-free joint.

[0118] Specifically, the apparatus and method of the present inventiondesigns and positions fasteners on malleable mounting structures so eachfastener grabs the vessel and pulls the inside edge of the vesseladjacent to the incision upwardly in an evagination movement whereby theinside surfaces of the vessels of the anastomosis joint adjacent to theincisions in these vessels are in abutting contact when the fastenersare being formed on the vessels. Still further, the fasteners arepositioned relative to each other so fasteners on one mounting structureassociated with one of the vessels are interdigitated with adjacentfasteners on the mounting structure associated with the other vessel.The interdigitated orientation of fasteners creates a sinusoidal shapefor the adjacent vessel edges. The sinusoidal shape of the abuttingvessel edges creates a leak-free joint and does not require a hemostaticmedium. The fasteners extend past the inside edge of the mountingstructure when formed. This outward projection evaginates the tissue andthe interdigitation of projecting fasteners causes the flexible vesseledge of one vessel to overlap the flexible vessel edge of the othervessel. The overlapping of tissue forms the leak-free joint. Theinterdigitation of fasteners on one structure with fasteners on theother structure forces tissue associated with the fasteners on the onestructure to be deformed by the fasteners on the other structure. Thedeformation creates the sinusoidal-like shape at the joint. Thissinusoidal-like shape has lobes that overlap each other; thereby formingthe leak-free joint.

[0119] Still further, the fasteners, also referred to herein as tines,are sized, positioned and set to achieve this goal. The spacing betweenadjacent tines of the ring-shaped stents embodying the present inventionis adjusted to achieve apparently counter-purpose goals. The tines arestaggered between one side and the other creating an interdigitation offasteners when the joint is formed. This allows compliance in the jointby opposing tissue-on-tissue and is referred to herein as a sinusoidaljoint due to the sinusoidal shape of the abutting tissue. In addition,for a given vessel thickness there is a range of optimum spacing betweenthe tissue retaining tines. Too many tines close together compress thetissue too much and lead to an increase of crush trauma. If the tinesare too far apart, the joint will not seal properly.

[0120] In another embodiment the malleable stents can be attached in, adifferent way. The vessel docking legs would have malleable protrusionsperpendicular to the body of the docking legs. The protrusions would bebent around the body of the docking leg on the artery side therebyaffixing the stents together.

[0121] In yet another embodiment the malleable stents can be attached byfolding or twisting or crimping the vessel docking leg over the arterydocking leg thereby affixing the stents together.

[0122] In yet another embodiment the malleable stents can be attached bypushing the vessel docking leg, which has a hole in it, over a postattached to the artery docking leg. The post would have a one-way barbor a rib on it to prevent the stents from coming apart. Another way ofpreventing the docking legs from separating is to have tabs protrudingfrom the hole on the vessel docking leg. This would create a one-way fitby binding against the post.

[0123] In yet another embodiment the malleable stents can be attached byrunning a spring-loaded clip down the guide suture and opening up overthe docking legs thereby capturing the legs. The spring-loaded clipwould have an integral cutter to sever the guide suture after it hasbeen mounted.

[0124] In yet another embodiment the malleable stents can be attached byplacing a suture loop over the mated docking legs. The suture loop wouldbe cinched, tied and cut thereby affixing the stents together.

[0125] Still further, the apparatus and method of the present inventionincludes means and methods for accurately and efficiently aligning amounting structure on one vessel with the mounting structure on theother vessel. The mounting structures of the present disclosure can beformed to include at least portions that are formed of absorbablematerial whereby at least a portion of the anastomosis joint will beabsorbed by the patient's body after the healing process is complete.

[0126] Still further, the present invention includes a cost-effectiveprocess for producing a malleable ring-shaped stent which will achievethe goals set forth herein for the anastomosis procedure.

[0127] The process includes a chemical double etch process. In thisprocess the planar pattern or pre-formed shape of the stent isduplicated on a sheet of material by a photo negative mask. The areasthat have been covered by the photo negative mask will not be etched bythe chemicals that the stent will be immersed into. Only the areas thathave not been masked will be etched. The malleable stent would be heldin place during the chemical bath through a series of carrier tabs. Oncethe sheet is removed from the chemical bath it would be re-masked with aphoto negative around the malleable body of the stent except for thetines. The sheet would be re-immersed into the chemical bath for a setperiod of time to create a dual taper on the tines producing a sharpbeveled point with rounded edges leaded to the point. Once the sheet isremoved with a multitude of ring-shaped stents, it would be passedthrough a progressive die where the tines would be formed and removedfrom the carrier sheet into the final shape. Additionally the carriersheet can be etched to create registration features which will provideexact alignment between the malleable ring-shaped stent and the tinesstill held in the carrier sheet for any secondary processes, such as dieforming or over-molding.

[0128] The present invention can accommodate increased demand flow andcorrespondingly increase the confluence section of the joint byproviding an oversized anastomosis. The device may alternately include amalleable ring-shaped stent made partially or entirely of a polymermaterial with tissue pins being metal. In some cases it is advantageousto make the stent from an absorbable material. There are a variety ofreasons to make the stent at least partially absorbable, but the mostbasic begins with the surgeon's desire to have a device that can be usedas an implant that will not require a second surgical intervention forremoval or that changes properties in the body over time. In addition ananastomosis may expand demand for increased blood flow increases as theheart becomes healthier. Absorbable polymers are well known in the art,for example, there are about 125 million absorbable sutures sold eachyear in the United States, see for example “Synthetic BiodegradablePolymers as Medical Devices” by John C. Middleton and Arthur J. Tiptonappearing in the March/April 1998 issue of “Medical Plastics andBiomaterials” at pages 30-39, the disclosure of which is incorporatedherein by reference. Absorbable sutures allow the surgeon tomechanically fasten tissue, while over a short amount of time the tissuewill remodel while the suture is absorbed into the body. The partiallyabsorbable malleable stent of the present invention uses absorbablesections as a mechanical means to join tissue; while over time thesesections will degrade thus freeing segments of the malleable stent togrow as needed. One form of the stent of the present invention hasmalleable sections and absorbable sections. In this stent thenon-absorbable malleable sections have interrupted sections that areimbedded in the polymer. Since absorbable materials are formulated tobreak down and become absorbed in the body at different times, thechemistry of the polymer can be designed to break down after the vesselwalls have had sufficient time to heal and create a structural bond.After that time, the integrity of the polymer stent will break down;therefore, the non-absorbable sections are free to move away from eachother allowing the anastomosis to grow if necessary. The number andpositions of the malleable sections and breakaway absorbable sectionsare determined by the overall size of the stent and the expected need toallow the anastomosis to expand.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

[0129]FIG. 1 is a schematic showing a heart.

[0130]FIG. 2 illustrates a prior art method of locating an incision inan artery for performing an anastomosis.

[0131]FIG. 3 illustrates an anastomosis which includes a hemostaticmedium located in a manner that clots will form externally of the bloodvessel.

[0132]FIG. 4 is a side view of a cuff which is included in the apparatusfor performing an anastomosis.

[0133]FIG. 4A is a view taken along line 4A-4A of FIG. 4.

[0134]FIG. 5 is an sectional view of the cuff taken along line 5-5 ofFIG. 4A.

[0135]FIG. 6 is an exploded perspective view showing a single cuff formof the invention prior to joining a graft and an artery.

[0136]FIG. 7 is a cut away view showing the single cuff form after thegraft has been joined to the artery.

[0137]FIG. 8 is an elevational cross-sectional view of the single cuffform of the invention joining a graft to an artery.

[0138]FIG. 9 is an exploded perspective view of one form of theinvention in which two cuffs are used to join an artery with a graft.

[0139]FIG. 10 is a perspective view of a section of the joined arteryand graft using two cuffs.

[0140]FIG. 11 is an elevational cross-sectional view of the two cuffform in situ.

[0141]FIG. 12 is an exploded perspective view of a tool used inperforming the anastomosis.

[0142]FIG. 13 is an exploded perspective view of the FIG. 12 tool usedin performing the anastomosis with a cuff in place.

[0143]FIG. 14 is a perspective view showing the FIGS. 12 and 13 tool inuse in placing a cuff on an artery.

[0144]FIG. 15 is an elevational view, with parts shown in section, ofthe FIGS. 12 and 13 tool in place in an artery just prior to setting acuff on the artery.

[0145]FIG. 16 is an elevational view of the FIGS. 12 and 13 tool inplace after a cuff has been set onto an artery and-just prior toremoving an anvil of the tool from the artery.

[0146]FIG. 17 is an elevational view of the FIGS. 12 and 13 tool with ananvil in place in a graft for placement of a single cuff form of theinvention.

[0147]FIG. 18 is an isometric section showing a two cuff device.

[0148]FIG. 19 is a sectional view of the FIGS. 12 and 13 tool in theprocess of forming the fasteners in an early step of the formingprocess.

[0149]FIG. 20 is a sectional view of the FIGS. 12 and 13 tool in theprocess of forming the fasteners in another step of the forming process.

[0150]FIG. 21 is a sectional view of the FIGS. 12 and 13 tool in theprocess of forming the fasteners in a late step of the forming process.

[0151]FIG. 22 shows a malleable ring-shaped stent attached to a vesselin a late stage of the fastener forming process.

[0152]FIG. 23 shows the malleable ring-shaped stent after it has beenstretched to permit removal of the anvil portion of the tool used toform the fastener.

[0153]FIG. 24 is a side elevational cross-sectional view of a completedanastomosis and shows the sinusoidal form of the joint at the abuttingtissue edges.

[0154]FIG. 25 also shows the sinusoidal-like shape of the joint formedbetween the two vessels.

[0155]FIG. 26 shows a cross section of a finished anastomosis.

[0156]FIG. 27 is a sine curve used to define the terms used in thisdisclosure.

[0157]FIG. 27A shows a histology cross section.

[0158]FIG. 27B is a magnified view from the central area of FIG. 27A.

[0159]FIG. 28 illustrates guiding a graft vessel into place on anartery.

[0160]FIG. 29A illustrates placement of the malleable support structurering-shaped stent on a graft vessel through use of a compact firing toolhaving a disposable cassette which holds the stent.

[0161]FIG. 29B is a longitudinal sectioned view through the compactfiring tool of FIG. 29A, showing the disposable cassette spaced from andabout to be inserted into the tool.

[0162]FIG. 29C is a longitudinal sectioned view of the compact firingtool of FIG. 29A, with parts thereof broken away, showing the disposablecassette inserted into the tool.

[0163]FIG. 29D is an exploded perspective view of the compact firingtool and cassette of FIG. 29A, with parts thereof broken away.

[0164]FIG. 30 is a longitudinal sectioned view of the cassette used inthe compact firing tool of FIG. 29A.

[0165]FIG. 31 is an exploded perspective view with parts thereof brokenaway, of a compact firing tool for placing the malleable ring-shapedstent on a vessel, wherein the stent is supported directly on toolwithout the use of a disposable cassette.

[0166]FIG. 32A is a perspective view of a loading cartridge which may beused to load a malleable ring-shaped stent directly on the tool of FIG.31.

[0167]FIG. 32B is a longitudinal sectioned view of the cartridge of FIG.32A.

[0168]FIG. 33A is a longitudinal sectioned view, with parts thereofbroken away, of the compact firing tool of FIG. 31 with the cartridge ofFIGS. 32A and 32B about to be used to load a malleable ring-shaped stentonto the tool.

[0169]FIG. 33B is a longitudinal sectional view, with parts thereofbroken away, of the compact firing tool of FIG. 31 with the cartridge ofFIGS. 32A and 32B engaged thereon to load a malleable stent onto thetool.

[0170]FIG. 33C is a longitudinal sectioned view, with parts thereofbroken away, of the compact firing tool of FIG. 31 with the cartridge ofFIGS. 32A and 32B released from the tool for removal.

[0171]FIG. 34A shows a portion of a tool used to set and manipulate amounting structure on a vessel.

[0172]FIG. 34B is an enlarged view of the distal end of the tool shownin FIG. 34.

[0173]FIG. 35A illustrates a ring-shaped stent engaged with guidesutures.

[0174]FIG. 35B illustrates guiding one mounting structure to the othermounting structure according to the teaching of this invention.

[0175]FIG. 35C shows portions of the two mounting structures of FIG. 35Bbefore they are guided into contact with each other.

[0176]FIG. 35D shows portions of the two mounting structures of FIG. 35Bjust before they are guided into contact with each other.

[0177]FIG. 35E shows portions of the two mounting structures of FIG. 35Bjust after they are guided into contact with each other.

[0178]FIG. 35F shows an alternative form of a means for holding the twomounting structures of FIG. 35B together.

[0179]FIG. 36A shows cassettes used to store and set mounting structureson a graft vessel.

[0180]FIG. 36B shows cassettes used to store and set mounting structureson an aorta vessel.

[0181] FIGS. 37A-37C show cross sectional views through the tip of adisposable cartridge as the malleable ring-shaped stent is placed.

[0182]FIG. 38A shows a clamp for attaching one mounting structure to theother.

[0183]FIG. 38B shows an elevational view of the clamp shown in FIG. 38A.

[0184]FIG. 38C shows the clamp shown in FIG. 38A in a closed condition.

[0185]FIG. 39 shows another form of a clamp used to attach one mountingstructure to another.

[0186]FIG. 40 shows the clamp shown in FIG. 39 in position on themounting structures.

[0187]FIG. 41 shows another form of the clamp used to attach onemounting structure to the other.

[0188]FIG. 42A shows another form of the clamp used to attach onemounting structure to the other.

[0189]FIG. 42B is an elevational view of the clamp shown in FIG. 42A.

[0190]FIG. 43A shows another form of clamp for holding two mountingstructures together.

[0191]FIG. 43B shows another form of clamp for holding two mountingstructures together.

[0192]FIG. 43C shows another form of clamp for holding two mountingstructures together.

[0193]FIG. 43D shows another form of clamp for holding two mountingstructures together.

[0194]FIG. 43E shows a portion of the FIG. 43D clamp just prior toengagement.

[0195]FIG. 43F shows a portion of the FIG. 43B clamp after engagement.

[0196]FIGS. 43G and 43H show another form of clamp for holding twomounting structures together.

[0197]FIG. 43I shows another form of clamp for holding two mountingstructures together.

[0198]FIG. 43J shows another form of clamp for holding two mountingstructures together.

[0199]FIG. 43K shows another form of clamp for holding two mountingstructures together.

[0200]FIGS. 43L and 43M illustrate a twist clamp for holding to mountingstructures together, with FIG. 43K showing the clamp open and FIG. 43Lshowing the clamp closed.

[0201]FIG. 44 shows a malleable ring-shaped stent attached to a graftvessel.

[0202]FIG. 45 shows a bottom view of the distal end of a docking guidetool.

[0203]FIG. 46 illustrates a flexible docking tool.

[0204]FIG. 47 illustrates the docking tool of FIG. 46 applying an O-ringto an in-place joint.

[0205]FIG. 48 illustrates cutting of guide sutures after the joint is inplace.

[0206]FIG. 49 illustrates a way of attaching two ring-shaped stentstogether.

[0207] FIGS. 50A-50C illustrate the attaching process for the stentshown in FIG. 49.

[0208]FIG. 51 shows a fastener element having a multiplanar shape so itwill form into the desired shape during the anastomosis procedure of thepresent invention.

[0209]FIG. 52 is an exploded perspective view illustrating the elementsassociated with the process for forming the malleable ring-shaped stentof the present invention.

[0210]FIG. 53 illustrates the resist image used to produce a pluralityof malleable stents.

[0211]FIG. 54 shows a chisel point formed in a single pass chemical etchprocess.

[0212]FIG. 55A illustrates a point configuration formed by the processof the present invention.

[0213]FIG. 55B shows an end elevational view of a tine formed by theprocess of the present invention.

[0214]FIG. 56 shows the body of a malleable ring-shaped stent formed bythe process of the present invention being re-masked on both sides ofetched stents.

[0215]FIG. 57 is a partial view of a finished sheet of malleable stentsformed according to the process of the present invention.

[0216]FIG. 58A shows a portion of a malleable ring-shaped stent of thepresent invention.

[0217]FIG. 58B shows a tine coincident with a connection tab.

[0218]FIG. 58C shows a malleable ring-shaped stent with at least onetine coincident with a connection tab that is used to connect the stentwith another stent.

[0219]FIG. 59 is a flow chart showing the process of the presentinvention.

[0220]FIG. 60 shows another form of the mounting structure of thepresent invention with absorbable portions.

[0221]FIG. 61 shows the FIG. 60 mounting structure in place after theabsorbable portions have been absorbed.

[0222]FIG. 62A is a top plan view of a malleable ring-shaped stentstructure showing spacing and size for the tines.

[0223]FIG. 62B is a perspective view of the stent structure shown inFIG. 62A.

[0224]FIG. 63 illustrates spacing and sizing for the best mode of themalleable stent of the present invention.

[0225]FIGS. 64A and 64B illustrate yet another alternative form of themalleable ring-shaped stent with manufacturing dimensions thereon.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT OF THE INVENTION

[0226] Locating and Performing the Arteriotomy

[0227] By way of orientation, FIGS. 1 and 2 indicate the procedure usedin locating and performing of an arteriotomy. As is well understood tothose skilled in the art, locating the position of an anastomosis isextremely important and extremely delicate. The location must beselected with extreme accuracy and precision. This is especiallynecessary since the blood vessels are often extremely small. This isindicated in FIGS. 1 and 2 where the location of a restriction isindicated as R and an arteriotomy is indicated at I in FIG. 2. Thearteriotomy must be made in a proper location with respect to therestriction R or the surgery will not be as effective as it could be.Furthermore, an anastomosis must be performed accurately and effectivelyto be successful. The present invention discloses and teaches a meansand a method of performing such an anastomosis.

[0228] As discussed in the parent applications, the present invention isintended to permit the performance of an anastomosis in a minimallyinvasive manner yet to perform the procedure in an accurate manner andin a manner that promotes proper healing. The most effective healingwill occur when the hemostatic medium is located on the outside of theblood vessel so any clots will form on the outside of the vessel. Thisbasic concept is illustrated in FIG. 3 which shows an anastomotic deviceAD comprising a hemostatic medium HM having a stent which includes afastening element FM for fastening the stent to the vessel and which islocated on the outside of one blood vessel B1 which is to be joined toanother blood vessel B2 and for bringing vessel walls, and theendothelial lining E1, of the one blood vessel into intimateapproximation with other vessel walls, represented by endothelial liningE2, of the other blood vessel whereby fibrin clot FC is formed in theproper location to effect a successful procedure. Still further,excessive clamping is avoided in the present invention by obviating theneed for clamps, such as are commonly used in prior art techniques.

[0229] Cuff

[0230] There are two forms of the invention, a single cuff form (seeFIGS. 11-18B of the parent and FIGS. 6-8 herein) and a double cuff form(see FIGS. 19-24 of the parent and FIGS. 9-11 here). In the interest ofbrevity, this mounting element will be referred to as a cuff. However,no limitation is intended by this shorthand reference.

[0231] The single cuff form of the invention has one portion mounted onartery A₁, and another portion mounted on graft blood vessel G₁ withvessels A₁ and G₁ being brought into contact with the vessel attachingelements of the cuff to attach the two vessels together. It is herenoted that for the sake of brevity, the discussion will be directed toblood vessels; however, those skilled in the art will be able tounderstand that the teaching can be applied to vessels of any sort thatoccur in a patient. Accordingly, no limitation is intended by thereference to a “blood” vessel. The double cuff form of the inventionshown in FIG. 9 has one cuff attached to graft G₂ and a separate cuffattached to artery A₂. These cuffs are then attached to each other toeffect the connection. The single cuff form of the invention has asingle cuff attached to both the graft blood vessel and to the artery,with the single cuff attaching the two blood vessels together to effectthe connection. The double cuff form of the invention has each cuffindividually mounted on a blood vessel by an instrument, and the twocuffed vessels brought together with the cuffs then coupled together.

[0232] Shown in FIGS. 4, 4A and 5 is a single cuff 40 embodying thepresent invention. The cuff is applied to a blood vessel and will couplethat vessel to another vessel or to another cuff. The cuff can beapplied to a blood vessel by an instrument while blood still flowsthrough the vessel by using a stabilizing cuff installation tool with aflow-through anvil. This enables anastomotic surgery to be performedwithout stopping the heart so the procedure can be carried out in aminimally invasive manner. The cuff also permits proper shaping of thejunction without mishandling the blood vessels and places the twovessels in an orientation that promotes efficient healing.

[0233] Specifically, cuff 40 includes an oval shaped flexible body 42having a long axis 44 and a short axis 46 with an oval shaped opening 48defined therein by cuff body waist section 49. The preferred form ofbody 42 is a woven fabric suitable for use in surgery. A stiffeningframework or stent 50 of malleable material, is integrated into body 42for retaining the cuff in a selected shape on a blood vessel. Thepreferred form of the framework is sinuous and includes a plurality ofmalleable sections, such as section 52. In the present context, thiselement will be referred to as a retention element. However, as willoccur to those skilled in the art based on the teaching of the presentdisclosure, depending on the context of the discussion, this element canalso be referred to as a “stent” or a “stiffening band.” One form of thematerial is a wire that is suitable for use in the surgical environmentassociated with this invention. The retention element has littlematerial memory in that once deformed from one shape into another, itwill not move back into the first shape from the second. A secondpotential form for the retention element is shaped from flat stock whichis processed using precise methods such as wire EDM or photo etching.Shaping the cuff is therefore efficiently carried out by deforming itinto the desired shape after it is mounted on a blood vessel. Theretention element will maintain the cuff in the shaped condition.Sections of the stiffening framework may be separate from othersections, such as quartered sections or the like.

[0234] Each malleable section has an apex, such as apex 54, with a cuffretaining pin, such as pin 56, thereon. Cuff retaining pins 56 attachthe stiffening framework 50 to the cuff, and anchor elements 58 attachbase 60 of each section 52 to body 42 to securely anchor the stiffeningframework to body 42. However, many cuff pins may be used to secure thecuff frame to the cuff.

[0235] As indicated in FIG. 5, tissue retention pins or fasteners 62 areattached at a proximal end 64 thereof to body 42 and have a distal end66 which engages a blood vessel to anchor the cuff to that blood vesselin the manner of a surgical staple. The instrument discussed below isused to force the retention pin into the blood vessel tissue to anchorthe cuff to the blood vessel.

[0236] Apparatus for shaping the cuff once it is anchored on the bloodvessel includes docking extensions, such as docking extensions 70 havinga proximal end 72 unitary with a base of a malleable section of thestiffening framework and a distal end 74 spaced from the outer perimeter76 of the cuff body 42. An eyelet 78 is located on distal end 74 havinga central hole 80 defined therein to engage a corresponding element onthe instrument used to place the cuff. The apparatus for shaping thecuff also includes a plurality of second docking extensions 82 havingproximal ends 84 integral with alternate apexes of the stiffeningframework 50 and a distal end 86 having an eyelet 88 with a central hole90 for releasable connection to a corresponding element on theinstrument used to place the cuff.

[0237] As was discussed in the parent application, the dockingextensions are engaged with the instrument, and once the cuff isanchored to a blood vessel, the instrument can be manipulated by thesurgeon to shape opening 48 to the desired size and shape. Once thedesired size and shape have been established, the cuff and framework isreleased from the instrument and will retain the desired shape and size.

[0238] As can be seen in FIG. 4, the cuff has an hour glass shape inelevation, with body 42 having a first end section 92 and a second endsection 94 of roughly the same outer dimension, with central section 95having an outer dimension of less than those outer dimensions. Otherforms of the single cuff are illustrated in the parent application withrespect to FIGS. 13A-13F.

[0239] As is also discussed in the parent application, the presentinvention can include a double cuff. As can be seen (see, e.g., FIG.11), one cuff 40′ is attached to a graft blood vessel G₂, and a secondcuff 40″ is attached to the artery A₂. As can be seen in FIG. 9, thereis a spacing S₂ between the fastening elements attaching the cuff to thevessel and the edge of the artery. This spacing is selected as the looseedge L₂ of the vessel can still be controlled, but the fastening elementis not located too close to the edge of the vessel. Bringing the cuffstogether in this manner does not mishandle the blood vessels andpromotes efficient healing of the junction. A spacing S₂ of ½ mm to 1 mmis shown in FIG. 9. However, this spacing is disclosed for the sake ofcompleteness and is not to be taken as limiting.

[0240] Referring to FIG. 9, means for joining one cuff to the other inthe double cuff form of the invention includes one unit 98 fixed to thegraft blood vessel G₂ and one unit 99 fixed to the artery A₂. A femalesection 100 is fixed to cuff 40′ and a corresponding male section 102 isfixed to cuff 40″. Female section 100 includes an eyelet 104 that has anopening sized and shaped to snugly receive a male element 106 mounted onsection 102 to establish a friction fit between elements 100 and 102that securely couples the two cuffs together. The preferred form of thecuff joining means includes four male elements and four female elementson each unit 98 and 99, each being located on opposite sides of thecuffs as is shown in FIGS. 22 and 23. Each cuff has two male elementsand two female elements with the male elements on each base whereby asecure attachment is effected.

[0241] As can be understood by those skilled in the art by comparingFIGS. 8 and 11, the double cuff form of the invention uses two cuffs,such as 40′ and 40″, to attach two blood vessels together, whereas, thesingle cuff form of the invention uses a single cuff 40′″ to attach twoblood vessels together. The double cuff form of the invention has twosimilar cuffs attached together by a coupling means. The single cuffform of the invention has a single cuff with the two ends thereofidentical each having a stiffening framework therein and each havingtissue retention pins 62′″ therein. A single body unitary 42′″ forms thecuff 40′″.

[0242] Both forms of the invention, the single cuff and the double cuff,can be used to form both a side-to-side anastomosis and the double cuffform can be used to form an end-to-side anastomosis.

[0243] The double cuff form of the invention is applied as indicated inFIGS. 9 and 11. A tool such as discussed in the parent application, isused to place a cuff on the graft, and then a second cuff on the artery.The vessels are then oriented adjacent to each other as indicated inFIG. 9, and then brought together so the two cuffs are coupled asindicated in FIG. 10. The cuffs are then coupled together as indicatedin FIG. 11 to form an end-to-side anastomosis or to form a side-to-sideanastomosis. The two cuffs are coupled together by a suitable fastener,such as the above-discussed male/female coupling shown in FIG. 11.

[0244] Instrument

[0245] As discussed above, the anastomosis technique of the presentinvention is intended to be performed in a minimally invasive manner.Therefore, the cuffs discussed above must be placed on blood vesselsthat are located inside a patient, with the artery carrying blood. Aswas also discussed above, the anastomosis technique of the presentinvention may involve extremely small blood vessels. Accordingly, theinstrument used to effect the anastomosis must be very accurate andprecise, and yet not mishandle the blood vessels during performance ofthe technique. The instrument will place a cuff on the artery whilepermitting blood to flow through that artery, and then will place acorresponding cuff on the graft blood vessel, or will attach the graftblood vessel to the single cuff mounted on the artery in the single cuffform of the invention. The instrument will then be used to shape thecuffs so the junction is the most efficient and will permit properhealing. All of this must be carried out in a minimally invasive manner.

[0246] The preferred form of the instrument used to mount a cuff to theartery in both forms of the invention and to mount the cuff to theartery and to the graft in the double cuff form of the invention isshown in FIGS. 12-17, with FIG. 13 showing a cuff in conjunction withthe instrument. Instrument 120 broadly comprises a handle frame 122having a handle 124 that is grasped by a surgeon during operation of theinstrument, and a finger frame 126 having a finger grip 128 which isoperated by the surgeon, two driver arms 130 and 132 pivotally attachedto the handle frame, a graft anvil 134 and an artery anvil 136.

[0247] More specifically, handle frame 122 includes a U-shaped sectionhaving legs 140 and 142 attached at one end to handle 124 and which arespaced apart to define a channel 144 therebetween. Each leg has aninside surface 146 with L-shaped anvil alignment slots 148 and 150defined in the legs to have short legs 152 that intersect the channeland long legs 154 defined to be parallel to the channel. The function ofthe anvil slots will be understood from the discussion in the parent andthe following discussion.

[0248] The handle frame further includes two ears 156 and 158. The earsinclude two spaced apart plates 160 and 162 with bores 164 and 166defined in each plate to be centrally aligned with each other for apurpose that will be understood from the discussion in the parentdisclosures. The handle frame further includes two rails 170, on theouter edges of the legs 140 and 142.

[0249] An undercut region 174 is formed in the proximal end of thehandle frame and provides a lip 176 having a top shoulder at the topentrance to channel 144. Lip 176 is U-shaped and has a channel 178defined between leg 180 corresponding to leg 140 and leg 182corresponding to leg 142.

[0250] Finger frame 126 includes a U-shaped base 184 having two legs 186each connected to a center section 190 and defining a channel 192therebetween. A slot 194 is formed at the intersection of each leg andthe center section, with slots 194 being sized and located to slidablyreceive rails 170. Sliding engagement between the rails and the slotspermits the finger frame to move with respect to the handle framelongitudinally of the channel 192 as is indicated by the double-headedarrow 196, with handle frame 122 moving in direction 198 with respect tofinger frame 126 to open the instrument anvils and moving in direction200 with respect to the finger frame to close the instrument anvils aswill be discussed below.

[0251] Each leg 186 of the finger frame 126 further includes an ear 202on a distal end thereof to which a guide pin 204 is fixed to extend pastthe handle frame leg adjacent thereto.

[0252] Instrument 120 further includes two pivot pins 206 and 208accommodated in the aligned bores 164 and 166. Each of the driver arms130 and 132 has a pivot pin receiving hole 210 and 212, respectively,defined in the proximal ends 214 and 216, respectively, of the arms.Crescent-shaped driver heads 218 and 220 are located on the distal endsof the arms 130 and 132, respectively, with cam slots 222 and 226 beingdefined in the arms 130 and 132, respectively.

[0253] The arms are pivotally attached to the handle frame by the pins206 and 208 to move in directions 227 and 228, as indicated bydouble-headed arrow 230, when finger frame 126 moves in directions 198and 200, respectively, to open and close the driver heads 218 and 220.Slots 222 and 226 slidably receive guide pins 204 to effect this openingand closing movement. Since the driver arms are secured to handle frame122 by pivot pins 206 and 208 and guide pins 204 move longitudinallywith respect to the handle frame and slidably engage cam slots 222 and226, longitudinal movement of the finger frame with respect to thehandle frame will cause the above-mentioned pivotal movement of thedriver arms. The opening and closing of the driver arms is illustratedin FIGS. 15 (closing) and 16 (opening).

[0254] Each driver head, 218, 220 has a V-shaped cuff-engaging edge 232which is sized and shaped to engage the waist section 49 of a cuff. Eachedge 232 also has two surfaces 234 that diverge away from each otherfrom the edge 232 to engage surfaces 236 and 238 (see FIG. 4)respectively of the cuff sections 92 and 94. Engagement of the surfaces234 with the surfaces 236, 238, along with movement of the anvils 134and 136, forces the tissue fasteners 62 into the tissue of the bloodvessel while shaping the cuff to the blood vessel.

[0255] The tissue fasteners must be turned in the manner of a staple inorder to fully connect a cuff to a blood vessel. Accordingly, instrument120 includes artery anvil 136 and graft anvil 134 which are removablyfixable to the handle frame. Graft anvil 134 includes a body 240 havinga threaded portion 242 on a proximal end thereof, a graft anvil head 244on a distal end thereof and alignment pins 246 between the two endsthereof. A fastening knob 247 is also included with instrument 120, andis internally threaded to threadably engage threaded portion 242.

[0256] Knob 247 is accommodated in undercut region 174 and threadedportion 242 is extends through channel 178 to be engaged by the threadedportion of the fastening knob 247. Longitudinal movement of the graftanvil in directions 260 and 262 is effected by threading the knob 247 onthe threaded portion 242. Threaded movement in one direction moves thegraft anvil in direction 262 and threaded movement in the oppositedirection moves the graft anvil in direction 260 whereby the location ofthe graft anvil head 244 with respect to the driver heads 218, 220 canbe adjusted and set. The purpose of this movement will be understoodfrom the discussion in this disclosure.

[0257] A groove 245 in knob 247 engages lip 176 of handle 124 to holdthe knob against axial movement as the anvil moves up or down to bend orcinch the fasteners 62. Body 240 includes a first portion 248 and asecond portion 250 that is angled with respect to the first portion 248.Graft anvil head 244 has a proximal end thereof fixed to portion 250 toextend transverse to longitudinal centerline 252 of the body 240. Thelength of body 240 as measured between its proximal and distal ends isgreater than the length of the handle frame as measured along itslongitudinal centerline 254 between the shoulder of the lip 176 anddistal end 256 whereby graft anvil head 244 is spaced from distal end256 when the graft anvil 134 is mounted on the handle frame. Firstportion 248 is also long enough so that graft anvil head 244 is alsospaced from driver heads 218 and 220 when the graft anvil is in place onthe handle frame. Alignment pins 246 are received through alignmentslots 148 and 150 and are slidably accommodated in slots 154 so thegraft anvil is securely and movably mounted on the handle frame.

[0258] Artery anvil 136 includes a body 270 having a threaded portion272 on a proximal end thereof and an artery anvil head 274 on a distalend thereof. Alignment pins 276 are located on the body to be receivedthrough short legs 152 of slots 148 and 150 and slidably accommodated onthe handle frame in the long portions of the slots 154. When the arteryanvil is attached to the handle frame, threaded portion 272 extendsthrough channel 178 and is threadably received by knob 247 to attach theartery anvil to the handle frame and to move that artery anvil indirections 260 and 262 with respect to the handle frame as was discussedabove with regard to the graft anvil whereby the location of the arteryanvil head 274 with respect to the driver heads 218, 220 can be set. Theartery anvil head 274 is located beneath the driver heads so that thehead can be inserted into an artery and a cuff being supported by thedriver heads will be located outside that artery. Once the artery anvilhead is positioned inside an artery, the knob 247 is operated to movethe anvil head 274 toward the driver heads 218, 220 until the cuffsupported in the heads 218, 220 engage the outside of the artery. Thetissue retention pins can then be set.

[0259] Artery anvil head 274 includes a bullet shaped body 280 havingtwo ends 282 and 284 with a bypass channel 286 defined longitudinallytherethrough from one end 282 to the other end 284. This channel permitsblood flow through the anvil head maintaining perfusion while the cuffis being attached. A fastener turning section 288 is defined in topsurface 290 of the head 274 adjacent to the intersection of the head andthe body 270 and in a location to receive ends 66 of the tissuefastening pins when they are forced through the blood vessel wall. Thefastener turning section is concave so the pin is turned as it engagesand follows the anvil head surface adjacent to the turning section. Thisrotates the fastener end so the fastener is gradually bent to a curvedshape, as shown in FIG. 16, for example. The tissue fastener is forcedto follow this turning section by engagement of the driver head surfaceagainst the cuff and against the tissue retention pins 62 as the heads218, 220 are moved into engagement with the cuff by operation of thefinger frame 126 and as the artery anvil is moved in direction 260 byoperation of the knob 247 on threaded portion 272.

[0260] Driver heads 218, 220 include docking pins 294 which releasablyengage holes 80 and 90 of the docking extensions 70 and 82 on the cuffto control the shape of the cuff. The friction fit between pins 294 andthe extensions 70 and 82 is great enough to permit the cuff to be pulledand shaped by movement of the driver heads, but low enough so the pins294 can be pulled out of the docking elements without pulling the cuffoff of the blood vessel. Alternatively, pins 294 could be retractedthrough a flexible shaft connected up to the handle. Pulling the driverheads outwardly in direction 227 will enlarge the junction and willchange its shape from oblong toward circular. Therefore, a surgeon canshape the junction in the manner that is most efficient to healing andto defining an effective anastomosis.

[0261] An assembled instrument is shown in FIG. 14 with an artery anvilbeing inserted through an arteriotomy I in an artery A and a cuff 40 onthe driver elements. As can be seen, once the incision is made, theartery anvil head is button holed into the artery via the incision. Theanvil head is actually larger than the incision in the artery but can beangled through the incision into position as shown in FIG. 14. The knob247 is operated to draw the anvil head and vessel surface at theincision up toward heads 218, 220. This action also isolates the workingarea from motion associated with the beating heart. As indicated in FIG.15, after the head supported cuff contacts the outside of the artery,driver heads 218, 220 are operated to force the edges 232 against thewaist section 49 and against the surfaces of the edges 236 and 238, andthe knob 247 is further operated to draw the anvil and the cufftogether. Further operation of the knob 247 forces the tissue fastenersthrough the blood vessel tissue, into turning section 288 and around onthemselves in the manner of a staple whereby the cuff is fixed to theblood vessel. During this operation, blood flows through the artery viachannel 286. Once the cuff is attached to the artery, the driver heads218, 220 are opened as shown in FIG. 16 so the anvil head 274 can beremoved from the artery. Since the cuff is connected to the driverheads, opening the driver heads will enlarge the incision therebypermitting the artery anvil to be removed.

[0262] The graft vessel is prepared in a similar manner. The graft anvilis inserted into the graft blood vessel via the end of that blood vesseland is tied to the graft anvil head 244 with a garroting suture. Thegraft anvil 134 is attached to handle frame 122. The instrument isoperated to attach a cuff to the graft blood vessel in a manner similarto that just described for attaching a cuff to the artery. Actually, thegraft is prepared first because the surgeon has more time to work on thegraft than on the artery. The graft anvil allows the surgeon to preparethe graft on the anvil first and then attach the anvil to the instrumentat a later time when it is convenient to do so.

[0263] The instrument is then maneuvered so the graft blood vessel isadjacent to the cuff mounted on the artery. The knob 247 is thenoperated to force the graft blood vessel into contact with the cuffportion that is not attached to the artery to attach the graft vessel tothe artery attached cuff. As shown in FIG. 17, the graft anvil head hasa fastener turning section 296 which operates to turn the fasteners inthat section of the cuff in a manner identical to the above-describedturning of the fasteners in the artery. This is illustrated in FIG. 17for a single cuff embodiment. Turning section 296 is used to turn thetissue retention pins to either attach a single cuff to the blood vesselor to attach a separate cuff to the blood vessel. Once the cuff isattached to the graft (for the single cuff embodiment), or the cuff onthe graft is attached to the cuff on the artery (for the double cuffembodiment) inside edges 26 and 26′ of the vessels are brought together(see FIG. 6), the driver heads 218, 220 are manipulated to enlarge thegraft incision to permit the graft anvil head to be withdrawn from thegraft vessel via the end of that vessel. The driver heads can then befurther manipulated to size and shape the junction, and then manipulatedto remove the docking extensions 70 and 82 from the docking pins 294 torelease the cuff or cuffs from the instrument. The graft blood vessel isthen tied off and the anastomosis is complete.

[0264] A sinusoidal shape for the joint is disclosed in the parentapplication (see FIG. 43 thereof). By careful and precise configurationof alignments between the two malleable ring-shaped stents and thefasteners, a leak-free joint can be formed. As the two malleablering-shaped stents are shaped, it is important to maintain the alignmentbetween the stents in order to create a leak-free joint. Alignment inthe present invention is maintained through the use of pins and socketswhich extend from the malleable stents, as discussed in the parentapplication. The pins and sockets not only align but also retain the twostents in compression to hold the stents securely together.

[0265] The parent application discloses both a single and a double stentfor forming the joint. It is noted that a sinusoidal shape for the jointrealizes the most significant benefits for the double stent embodiment.

[0266] Shown in FIG. 18 is a two cuff device 10C in which a firstmalleable ring-shaped stent 12C is mounted on a first vessel 13Cadjacent to an incision 14C in the first vessel, and a second malleablering-shaped stent 16C mounted on a second vessel 18C adjacent to anincision 20C defined in the second vessel.

[0267] The stents are identical, therefore, only one stent will bediscussed. Stent 16C includes a body 22C having an inner edge 24Clocated closely adjacent to edge 26C of vessel 18C. Edge 26C is formedby the vessel 18C adjacent to the incision 20C. Body 22C furtherincludes an outer edge 28C, with the body being located between theinner and the outer edges 24C and 28C.

[0268] Stent 16C also includes two coupling elements 30C and 32C (whichis shown on stent 12C for ease of illustration). As shown, element 30Cincludes a body 34C integrally fixed to body 22C to extend beyond inneredge 26C and which has a pin-receiving hole 36C near a distal endthereof. Element 30C is flexible so it can be distorted near hole 36Cand will flex and then return to the shape shown in FIG. 18. Element 32Cis integrally attached to the stent body to extend past the inner edgethereof and has a locking pin 38C thereon near a distal end thereof inposition to be received in hole 36C to couple the two stents together.An element 30C is on one portion of each stent and an element 32C is onanother, diametrically opposite, side of the stent so the stents can becoupled together. As shown in FIG. 18, the-coupling elements lie in thesame plane as the bodies of the malleable stents. Therefore, when thecoupling elements are rotated, the stent bodies will correspondinglyrotate. The purpose of this rotation will be understood from thefollowing disclosure.

[0269] Referring next to FIGS. 18-21, it can be seen that each stentincludes a plurality of fasteners 40C. All of the fasteners areidentical, therefore, only one fastener will be described. Fastener 40Cincludes a proximal portion 42C integrally fixed to body 22C adjacent toouter edge 28C and a distal tip 44C. As can be seen in the figures, body22C is located between fastener proximal portion 42C and inner edge 24C.

[0270] When the fasteners are formed, the tip 44C is forced around andtoward inner edge 24C as can be seen by comparing FIGS. 19-21. Thefastener is forced through the vessel wall, around and toward inner edge24C to mount the stents on the vessel adjacent to the incision. As canbe visualized, such movement grasps the vessel wall and pulls it towardthe incision. The vessel wall is thus captured and controlled during thefastener forming process thereby improving the accuracy of the jointforming process over the prior art.

[0271] As can be seen in FIG. 21, the formed fasteners have a portion46C that extends beyond inner edge 24C. The stents can be oriented in avertical manner (see FIG. 26) or in a horizontal manner (see FIGS. 24and 25) after coupling. Depending on the coupled orientation of thestents, the fasteners are formed accordingly so the tip is closelyadjacent to the inner edge of the body in the horizontal orientation,and somewhat spaced from the inner edge of the body in the verticalorientation. In either orientation, the vessel wall is grasped androtated toward the incision to force the vessel wall adjacent to theincision to rotate about the outer edge of the body. This evaginates thevessel wall to expose the intima, or inner surface, of each vessel tothe intima, or inner surface, of the other vessel.

[0272] As can be seen in the figures, some portion of each fastenerprotrudes beyond the edge of the vessel adjacent to the incision. As canalso be seen in the figures, especially FIGS. 24 and 25, fasteners onstent 12C are staggered with respect to fasteners on stent 16C. This isillustrated in FIGS. 24 and 25 by fasteners 40 aC and 40 bC. Thisstaggered relationship interdigitates the fastener 40 aC between the twofasteners 40 bC on either side of fastener 40 aC when the joint J isformed.

[0273] The interdigitation of fasteners combined with the protrusion ofa portion of each fastener beyond inner edge 24C of each stent, causesthe vessel wall to be deformed by the fasteners when the stents 12C and16C are coupled together to form a joint. The deformation of the vesselwalls takes the form of a sinusoidal-like shape as best shown in FIGS.24-26. For the sake of clarity of description, a sinusoidal function isshown in FIG. 27 along an x-axis and a y-axis. The function includeslobes L1 and L3 formed by the intersection I₁ of the function with thex-axis. Lobe L1 will be referred to as a positive lobe, and lobe L3 willbe referred to as a negative lobe. As shown, lobes L1 and L3 areadjacent to each other, and lobe L1 includes a maximum point P1 whilelobe L3 has a minimum point P2.

[0274] Comparing FIGS. 26 and 27, it can be seen that the anastomosisjoint J is sinusoidal in shape and includes lobes L1 and L3 formed bythe vessel walls that have been deformed by the fasteners. As shown, thefasteners are located opposite to the maximum and minimum points P1 andP2 with these points being located adjacent to the tips of thefasteners.

[0275] Further, as indicated in FIG. 26, the joint includes couplingelements 30C and 32C. These elements act like compliant springs whichgently press on the stent to ensure a secure clamping of the stentagainst the interposed tissue. The interposed tissue can act like acompliant seal as well whereby an adjustable hemostatic joint isdefined. Still further, the stiffness of the joint is a function of thecompliance of the malleable ring-shaped stent. Thus, by varying thethickness and dimensions, such as the width, of the stent, the stiffnessof the joint can be influenced. By adjusting these same characteristics,including the length dimension, of the docking legs, the amount ofpressure applied to the tissue to hold the stents together can bealtered. This discussion applies to both the single cuff configurationas well as the double cuff configuration such as shown in FIG. 11.

[0276] As discussed above, the overlapping nature of the lobes of thejunction seals the junction and creates a leak-free joint. It is alsonoted that the cross-sectional shape of the malleable ring-shaped stentsis not necessarily a limiting factor in the joint configuration, andmany shapes can be used without departing from the scope of the presentdisclosure.

[0277] It is also noted that the stents and coupling means could beinjection molded from a plastic polymer and the fastener legs could bemade from wire. In this manner, the fasteners would be captured on thepolymer base. The polymer base could also be made of an absorbablematerials such as that used in absorbable sutures. In addition, a singlewire loop could be embedded into the polymer in order to make it retainits shape when it is opened to allow removal of the anvil from thevessel. Once the polymer is absorbed, the wire ring and fasteners willremain on the outside of the vessel. This will not cause a problem sincethe tissue will have healed by that time.

[0278]FIG. 27A shows a histology cross section of the healing process ofan anastomotic joint that has been prepared by those who are skilled inthe art of pathology. This is a standard means for a pathologist tostudy tissue at the cellular level. Tines 100F are from the proximalside or the graft side. Tines 101F are from the distal side or theartery side. FIG. 27B is a magnified view from the central area of FIG.27A. This shows the metal tines 100F and 101F associated with aninterposed sinusoidal zone 103F of reparative tissue 104F. This tissueis composed primarily of a solid ingrowth of dense fibrous tissue. Thereis minimal evidence of old hemorrhage.

[0279] Method

[0280] The method of forming joint J is discussed in the parentapplication with respect to FIGS. 41-42B thereof. Accordingly, thedetails of placing the anvils, button-holing the artery anvils, and thelike will not be presented here, but reference is made to thejust-mentioned disclosure in the parent application. The details of themethod steps used to form the particular fasteners 40C and the formationof joint J will be presented.

[0281] After an incision has been made in the vessel, an anvil 50C isbutton-holed into the vessel as indicated in FIG. 19. The anvil has astem 52C which extends out of the patient. A cutter 54C is associatedwith the anvil to move in directions 56C and 56C′ by operation of anappropriate handle located outside the patient. Cutter 54C includes acutting edge 58C located near anvil pocket 60C. Anvil pocket 60C isconcave and a second concave cutout portion 62C is located at theintersection of the anvil body and the anvil stem. The anvil body alsoincludes a flow passage 64C as discussed in the parent application soblood can continue to flow in the vessel during the procedure.

[0282] Stent controlling jaws 66C and 68C have ring-shaped stents seatson a distal end thereof to releasably mount ring-shaped stents 12C and16C thereon.

[0283] In FIG. 19, the stents with the fasteners are shown on the jaws.The anvil has been inserted into the lumen of the vessel. The anvil isfirst pulled up against the fastener legs which causes the legs topenetrate the vessel and the wall and begin to turn in the anvilpockets. This is the first important step in controlling the edges ofthe tissue. By setting the fastener legs into the vessel wall first, theedges of the tissue are captured so they cannot move out from beneaththe cutter during the trimming process.

[0284] In FIG. 20, the cutter is progressing downward and is trimmingoff any excess tissue at the edges. The fastener legs, however, arestill penetrating the vessel wall and holding it in place while thecutter is trimming.

[0285] In FIG. 21, the anvils and the jaws have completed the forming ofthe fastener which turns the fastener legs inward toward the incision.This captures the edge of the vessel wall securely and rotates it uptoward the inside edge of the malleable ring-shaped stents.

[0286] In FIG. 22, the malleable ring-shaped stent is shown as it wouldappear in the last stage of crimping before being opened to allow theanvil to be removed. As shown in FIG. 22, the malleable stent is on theoutside. The fastener legs have penetrated from the outside edges of thering-shaped stents and have gone through the vessel wall and have comeup forward toward the incision thus bringing the vessel wall out towardthe opening shown in the center.

[0287]FIG. 23 shows the malleable ring-shaped stent being stretched toallow exit of the anvil and to increase the cross sectional flow area.This is the final stage before the two stents are joined to make acomplete anastomosis.

[0288] It is also noted that the stents can be joined together using atool such as disclosed in the parent application in FIGS. 38-40.Furthermore, the tool used to operate the anvil will not be discussed,since the tool per se does not form a portion of this invention. It isonly noted that such a tool needs only to include some form of handle tomove the anvil in the manner discussed above, and to move the cutter inrelation to the anvil to perform the cutting function discussed above.Suitable handles are known to those skilled in the art from disclosuressuch as the parent disclosures.

[0289] As discussed above, proper and accurate alignment of the elementsassociated with the anastomosis is difficult, but necessary. In view ofthe above, the present invention includes apparatus and methods forproperly and accurately guiding and aligning the elements.

[0290] In cardiovascular surgery, surgeons are very familiar with theplacement of sutures between the annulus of a heart valve and aprosthesis. The Illustrated Handbook of Cardiac Surgery by Harlan, Starrand Harwin describes this common method of attachment of valves. Themethod described includes first placing sutures in the heart tissue,spacing them accordingly, then setting the sutures into the prosthesisat the same spacing. The valve can then be guided into place in theannulus by sliding it down the taut sutures to seat in the aortic root.Therefore, a surgeon may be familiar with a procedure which utilizesguide sutures to align and dock one element to another. The inventionherein takes advantage of this and applies it to the anastomosisprocedure. Accordingly, as shown in FIGS. 28-30C, guide sutures 400 areanchored at tab 401 to a target stent 402 which can be either theproximal stent on the aorta or the distal stent on the coronary artery.There are pass-through holes 404 in the stent 406 attached to the graft.The pass-through holes 404 allow stent 406 to ride on the suture guides400 to find its place in perfect alignment when it comes into contactwith the target stent 402. This removes the requirement of fine motorcontrol and visual access when joining stents.

[0291] The docking portion of the procedure can be very difficult due tothe small size of the artery, the graft vessel and the stents. Tool 410permits remotely controlled proper docking to place the malleable stentstogether in the correct configuration and a means to join the twomalleable stents together assuring a leak-free anastomosis.

[0292] Stent docking and guide tool 410 is shown in FIG. 28 and is usedto manipulate the vessels in remote, limited access surgery. The tool isused to guide the ends of the graft without unnecessary manipulation ofthe graft tissue and also facilitates the final attachment of a clampingor locking means between the two stents to permanently hold themtogether in approximation.

[0293] Tool 410 places the malleable stents together and includes a longshafted handle 412 having a hand grip 414 on one end and a nest 416 onthe distal end to accept the malleable stent and a mechanism operablyconnecting a trigger in the hand grip to the nest to release the stentfrom the nest when the surgeon operates the trigger once it has beenattached to the artery or graft. When the surgeon is ready to place themalleable stents together the first step is to load the malleable stent,on the graft vessel, in the distal end of the docking guide tool. Thesurgeon will place the stent into the distal end of the tool while he isdepressing the trigger on the handle at the proximal end of the dockingguide tool. This malleable stent will lock into the docking guide tool.The surgeon will now guide the graft down onto the artery stent by usingthe guide sutures that are attached to the artery malleable stent. Thesutures are also run through the graft stent or guided through thedocking tool. A parachuting technique will be used to bring the twostents together. It is extremely important that the docking guide toolbe small enough at the distal end for the surgeon to see when the stentshave been mated. Once the stents are together the surgeon must attachthe stents together. On the malleable stents there are four dockinglegs. These will be used to hold the malleable stents together forming aleak-free anastomosis. While the surgeon is holding the graft stentagainst the artery stent, a docking tool will be used to attach thestents. The docking tool is a long narrow tool that will join the stentlegs. In one embodiment the docking guide tool will deploy a smallO-ring that will slide over the docking legs on the malleable stentsthereby locking the stents together. Once the surgeon has placed anO-ring on all four docking legs the stents are permanently attached toeach other. The legs have anti-backup features to prevent the O-ringfrom coming off the leg. The surgeon will now depress the trigger on theproximal end of the docking tool and the malleable stent will bereleased from the docking tool. Once the docking tool is removed thesurgeon is free to cut the guide sutures from the anastomosis. Thisprocess will be repeated for the other anastomosis.

[0294] The process of docking two stents using guide sutures 400 isillustrated in FIGS. 28 and 35B-35E. Target stent 402 has pre-tiedsutures 400 anchored thereto by pre-tied knots 420 attached to tabs onthe stent, such as eyelets 78 and/or 88 shown in FIG. 4A, with the stentbeing attached to an artery. Sutures 400 extend away from target stent402 and extend through holes 404 in tabs 405 of stent 406. Stent 406with the graft vessel attached thereto is slid down the sutures intocontact with target stent 402. The stents automatically align with eachother as indicated in FIGS. 35D and 35F due to the guide sutures.

[0295] Once the surgeon has placed the malleable stents on the graftvessel and the artery, as mentioned previously, the next step is toattach the two malleable stents together forming a leak-freeanastomosis. FIGS. 44, 45 and 28 show malleable stent 406 attached tothe graft vessel G₁. The surgeon will place docking guide tool 410 overstent 406 while depressing trigger 666 in direction 667 on the proximalend of the docking guide tool. FIG. 45 shows a bottom view of the distalend of docking guide tool 410. By depressing trigger 666 (see FIG. 28)in direction 667, leg retention bars 668 are retracted, allowing dockinglegs 669 to seat within nest 416 of docking guide tool 410. Oncemalleable stent 406 is seated within nest 416, the surgeon will releasetrigger 666 thereby allowing leg retention bars 668 to close and trapmalleable stent 406 within docking guide tool 410. FIG. 28 showsmalleable stent 406, attached to docking guide tool 410. The surgeonwill now slide malleable stent 406 mounted in the graft vessel ontotarget stent 402 mounted on the coronary artery by applying tension tothe guide sutures 400. Once the stents have made contact and are seatedtogether the docking tool will be used to permanently join the stentstogether.

[0296]FIG. 46 shows a docking tool 672 for remotely docking stentstogether. The proximal end of docking tool 672 has a flexible collar 673that rides over a flexible core shaft 674. Docking tool 672 is flexiblethereby allowing the surgeon to deform the shaft to gain access to thejoined docking legs of the malleable stents. The surgeon will loadO-ring 675 onto flexible core shaft 674 at the distal end of dockingtool 672.

[0297]FIG. 47 shows once O-ring 675 is fully seated at the distal end ofdocking tool collar 673 the surgeon will place countersink tip 676 offlexible core shaft 674 on the joined ends of the docking legs 677. Thejoined ends of docking legs 677 will be nested into countersink 676 offlexible core shaft 674. At this point, the surgeon will be able feelthe docking tool is attached to docking legs 677 and he will slideflexible collar 673 in direction 678 displacing O-ring 675 from flexiblecore shaft 674 onto the joined ends of docking legs 677. O-ring 675 willride over retention bumps 679 integral with docking legs 677 and beseated. This process will be repeated until all four legs of themalleable stents are joined. Once the surgeon has validated theanastomosis is leak-free he can now cut guide sutures 400 as shown atsuture cut 680 in FIG. 48.

[0298] The following will show many different ways to join malleablering-shaped stents together by deforming one or both docking legs. FIGS.49 to 50C show another way to attach the docking legs together. Themalleable stents attached to the graft vessel have two legs 681 that areperpendicular to the docking legs. Legs 681 will be formed around thedocking leg 682 of a mating malleable stent. After the docking guidetool has placed the malleable stents together, a crimping tool 683 isplaced at the end of the docking leg. An anvil 684 will hold the dockinglegs together while a sliding tube 685 will cam jaws 686 togetherforming legs 681 around the body of docking leg 682 as shown in FIGS.50A-50C.

[0299] Once the two stents are in proper alignment with each other, theyare clamped together. While various means can be used to clamp thealigned stents together, the preferred clamp is shown in FIG. 35E asclamp 422 which is slid down each suture 400 into contact with thealigned stents. Clamp 422 is a spring clamp which is biased into aclosed configuration and is held open as it is moved by a tool along thesuture and into the FIG. 35E position. Clamp 422 has two suture engagingjaws 424 which, when released, securely engage the suture to hold theclamp in position. The combination of clamp 422 and knot 420 maintainthe stents 402 and 406 in a locked condition.

[0300] While clamp 422 is shown, other elements can be used to hold thetwo stents together. As shown in FIGS. 38A-42B, various clamp elementscan also be used without departing from the teaching and scope of thisdisclosure. Thus, the clamp can include a corrugated body 426 as shownin FIGS. 38A-38C for clamp 422′ which includes opposed cutting edge 428and shear edge 429 that overlap each other in the manner of a scissorjoint adjacent to a top bend 430 that orients the cutting edges in acutting position to snip suture 400 as indicated in FIG. 38C. Otherbends in body 426 serve to adjust the spring tension of the body.

[0301] Clamp 422′″ is shown in FIG. 39 in an unfolded form as includinga body 426′ having a suture hole 432 as well as cooperating cross-overcutouts 434 and 436, cutting edge 428′ and shear edge 429′. The in placeclamp 422″ is shown in FIG. 40. An alternative form of the cutting edgeis shown at 428″ for clamp 422″ illustrated in FIG. 41 with a shear edge429″ cooperating therewith.

[0302] Yet another form of the clamp is shown in FIGS. 42A and 42B ascross-leg clamp 422′″. Clamp 422′″ is positioned on the outside of stenttabs 401 and 406′. Clamp 422′″ is in the nature of an allegator clampwith jaws 440 and 442 engaging tabs 401 and 406′ as shown in FIG. 42B toexert pressure on those tabs as indicated in FIG. 42B by arrows 444.Suture 400 extends through clamp 422′″ via a suture guide hole 446.

[0303] A suture chock 448 can be positioned on the suture adjacent tothe clamp to hold the clamp in place as shown in FIGS. 35F and 42B.Chock 448 includes a spring element 449 to enhance the friction fitbetween chock 448 and the suture.

[0304] Other variations of the docking elements are illustrated in FIGS.43A-43J. Referring to FIG. 43A, tab TC on one stent includes two legswhich diverge radially outward from the body of the stent to form aV-notch into which a projection PC on the other stent is received foraligning the two stents to form a lock LC. The lock LC is self-orientingsince projection PC will be guided into place by the legs on tab TC.Once projection PC is in place in the V-notch, it can be bent over thetab TC to twist and lock the two stents together.

[0305] Yet another means for locking the two stents together is shown inFIG. 43B as including a tab AC on one stent and a tab BC on the otherstent. The tabs AC and BC have off-set edges AC1 and BC1 thatinterengage when the tabs are aligned and brought together.

[0306] A snap fit is shown in FIG. 43C in which a tab CC is on a firststent and extends radially outward therefrom. A second tab DC is on theother stent and has a clamping slot defined therein for accommodatingtab CC to form a locked joint LC′. When tab CC is properly aligned withtab DC, tab CC will be received in the clamping slot as shown in FIG.43C to properly align the two stents with regard to each other so thefasteners, indicated by reference indicators F1 and F2 in FIG. 43C, areinterdigitated as discussed above to define the sinusoidal joint of thepresent invention. Tab CC also includes a slot CC1 to enhance theflexibility of the tab so it can move into and out of the slot in tab DCyet will be securely held therein.

[0307] Yet another variation of the locked joint between the two alignedstents is shown in FIG. 43D as joint LC″. Joint LC″ also alignsfasteners F1 and F2 to be interdigitated when the two stents are lockedtogether and includes a tab DC′ on one stent and a tab EC on the otherstent. Tab DC′ includes a slot DCS having a lead in area defined byconverging edges on legs DCL and a receiving slot DCR adjacent to theedges on legs DCL. A spring leg ECL is located to move through the leadin area of slot DCS as indicated in FIG. 43E and to engage tab DC′ whenit is accommodated in area DCR to lock tab EC to tab DC′ as indicated inFIG. 43F. FIGS. 43L-43M illustrate tab DC″ and DC′″ which are secured bytwisting extensions DC″″ and tab DC″ around the tab DC′″ to join twomalleable mounting structures together.

[0308] Still another way to join the malleable stents together is shownin FIGS. 43G and 43H. Malleable stent R_(A) is attached to the arteryand has protruding posts PP. The malleable stent R_(A) is attached to astent R_(G) on the graft vessel. Stent R_(G) has a cutout CF formed withinterfering tabs CFT. When the two malleable stents R_(A) and R_(G) arebrought together cutout CF is forced over protruding posts PP causinginterfering tabs CFT to bind thereby holding malleable stents R_(A) andR_(G) together. FIG. 43I shows a protruding post P′ with directionalbarbs DB attached thereto. FIG. 43J shows a protruding post P″ with asingle detent SD. FIG. 43K shows a protruding post P′″ with multipledetents MD. The post P′, P″ and P′″ may be used in place of the postsPP.

[0309] It is also noted that the docking elements, such as tabs 401 and405 shown in FIGS. 35B and 35C of the malleable mounting structures canbe magnetized to ensure proper alignment and docking. Also, rivets,similar to posts PP, can be used to attach to mounting structurestogether.

[0310] Cassette Loaded Firing Tool

[0311] A compact cassette loaded firing tool 450 for placing the stentsis shown in FIGS. 29A, 29B, 29C, 29D and 30. Tool 450 is used inconnection with cassettes 452 and 454 which are respectively associatedwith artery stent 402 and graft stent 406 (see FIG. 36B). The cassettes452 and 454 are of the same construction. The following description ofcassette 452 applies equally to cassette 454. Each cassette includes ananvil stem 456 having an attaching prong 458 on one end and an anvil 460on the other end. A housing 461 slidably receives the stem 456 andprovides a stent supporting platform 462 between the anvil and attachingprong. An annular cutter assembly ring 463 is slidably received in thehousing 461 and has radially extending blades 464 disposed to oppositesides of the stem 456 for extension from the distal end of the housing461. An annular driver 465 is slidably received within the cutterassembly for extension from the assembly by the stem receiver 471 b.

[0312] Tool 450 includes an operating handle 470 on one end of a tubularbody 472 with the cassettes being releasably mounted on the end 474 ofthe body. The proximal end of the body is formed with a first transversefinger grip 484 a. An attaching groove 471 on prong 458 releasablyreceives a stem lock 471 a (see FIG. 29C) on stem receiver 471 b toreleasably hold cassettes 452, 454 on tool 450. The stem lock 471 a isoperably connected to a release button CRB on tool 450. When button CRBis depressed the stem lock 471 a is withdrawn from groove 471 therebyreleasing cassette 452 from the tool. The cassette can then be removedfrom the surgical site by hand or the like. The cassette is disposable,and the instrument itself can also be disposable, if desired. Otherwise,the instrument can be re-usable if suitable.

[0313] The stem receiver 471 b is slidably received in a tubularspreader bar carrier 630 which, in turn, is slidably received in thebody 472. The proximal end of the spreader bar carrier 630 terminates ina thumb ring 486 a. A second transverse finger grip 484 b is fixed tothe proximal end of the stem receiver 471 b and extends through alignedslots 630 a and 472 a, respectively, therefore in the carrier 630 andbody 472. A first compression spring 471 c is received between the stemreceiver 471 b and the proximal end of the spreader bar carrier 630 tonormally urge a second finger grip 484 b and thumb ring 486 a apart. Asecond compression spring 484 c is received between the first and secondfinger grips 484 a and 484 b to normally urge these grips apart.Spreader bars 640 are pivotally received to the spreader bar carrier 630and extend therefrom through the distal end of the body 472 and toopposite sides of a cassette received thereon. The spreader bars 640 arefor purposes of spreading a ring-shaped stent after it has been crimpedinto place. Their structure and operation will be described in detailwith respect to FIGS. 34A and 34B.

[0314] The distal end of the spreader bar carrier 630 is proportioned toslidably receive the cutter assembly ring 463 and is formed with ashoulder 631 for abutting engagement with the ring. Upon advancement ofthe carrier 630, such engagement serves to extend the blades 464. Thedistal end of the stem receiver 471 b is proportion to slidably extendthrough the ring 463 into abutting contact with the driver 465 to extendthe driver.

[0315] In operation, the anvil 460 is first button holed into a vesselto which the stent is to be attached. The second finger grip 484 b isthen pulled toward the thumb ring 486 a to retract the stem receiver andcinch the fastener tines of the stent to the vessel. The end of thisstroke extends the driver 465 and activates the vessel cutting blades464 to properly size the arteriotomy and free the edges of the vesselwall for proper tissue eversion. The finger grip 484 b is then releasedand the thumb ring 486 a is depressed relative to the first finger grip484 a to advance the spreader bar carrier 630 relative to the body 472and activate the spreader bars 640 to spread the stent. (This mechanismis seen and described with respect to FIGS. 33, 34 and 35.)

[0316] After the stent is spread, the stent and anvil are released fromthe cassette and the anvil is removed from the cassette and button-holedout of the arteriotomy. The cassette is then removed from the tool and anew cassette is loaded into the tool in its place. Thus, the tool isagain conditioned for the placing another stent.

[0317] The operation is repeated on the other vessel. The two vesselsare brought together using the sutures 400 or the other docking meansdescribed above to orient the stents in the proper position relative toeach other with the fasteners interdigitated, and then clamped together.

[0318] The following is a brief description of the sequence of eventsnecessary to load and fire the compact firing tool.

[0319] The cassette 452 is loaded into the compact firing tool.

[0320] The groove 471 of the anvil stem is engaged by the stem lock 471a.

[0321] A small incision is made in the artery.

[0322] The anvil is placed into the small incision in the artery.

[0323] The anvil is centered within the small incision.

[0324] The tines puncture the artery wall and are formed on the anvilduring the initial firing.

[0325] The integral knife extends the incision within the perimeter ofthe stent to the correct size and precisely locates and opens theincision to the correct size based on malleable stent size.

[0326] The knife is retracted within the compact firing tool.

[0327] The malleable stent is spread open to the correct size.

[0328] The malleable stent is released from the compact firing tool.

[0329] The anvil is released from the compact firing tool.

[0330] The anvil is removed from the incision in the artery.

[0331] After the disposable loading cassette has been loaded on thecompact firing tool, the surgeon will attach the malleable stent to thebypass graft. The end of the graft will be prepared as the firing toolis positioned to attach the malleable stent. The compact size of thefiring tool allows the surgeon the visual access needed to place thestent on the graft or artery. Once the surgeon has determined thelocation of the malleable stent, the anvil of the firing tool must beplaced into the lumen of vessel through a small incision known as anarteriotomy. The anvil must be seated within the arteriotomy withoutbunching or tearing tissue. It is also important that the vessel wall isnot stretched too tight on the anvil or it will cause the vessel wall totear. Placing the anvil in the vessel will be done in a techniquesimilar to placing a large button through a slit, by placing the buttonon edge and slipping it through the slit. Now the anvil is on the insideof the lumen and the malleable stent is fixated in the firing tool onthe outside of the vessel. The surgeon will now activate the firing tooland the stent will move towards the anvil. Once the tines of themalleable stent penetrate the vessel wall, they will make contact withthe pockets located in the anvil. At this moment the tines will start todeform and roll back inside the vessel, towards the firing tool.

[0332] The tool should be small enough to be operated with one hand andwith some type of feedback on when the stent has begun to fire and whenthe firing sequence has been completed. The tool should also beversatile enough to be placed on any location on the surface of theheart that is currently accessible today in a traditional procedure.

[0333] During this firing series several important steps have occurred.First, the surgeon started the initial firing operation, locking thetissue and the stent. When producing a device as small as required inthis application, many design issues are not readily apparent. Forinstance, the need to make the tines very thin and sharp to preventleaks. Being so thin it makes them too fragile to drive into tissue inan unsupported manner. Therefore the tines must be shrouded to protectthe sharp tips from being damaged and fully supported during firing toprevent unwanted buckling. The tines of the stent must be fullysupported throughout the entire firing sequence. If not, they willbuckle and form an undesirable non-functional ring. Even when the distaltips of the tines have penetrated the vessel wall and made contact withthe anvil, the proximal ends of the tines are fully supported with atine backing plate. The manner in which the tines are formed is atightly controlled buckle. Second, the driver 465 has made contact withthe tip of the deformed tine bending them back over thereby locking onthe tissue. When this occurs the tissue is not crushed due to the natureof the tine deformation on the secondary anvil. When the driver 465 isdeployed, the cutter blades 464 are also deployed to make a preciseopening within the perimeter of the stent that creates the openingthrough which the blood will flow. The size of the opening is based onthe malleable stent size. It is important to size this correctly toavoid tearing of the tissue upon stretching the stent. If too large,there will not be enough wall area from the edge of the opening to theedge of the tine. This may cause the vessel to tear inducing a leakunder the stent.

[0334] The next step the tool will perform is to spread the malleablestent to the predetermined opening size. The malleable stent is placedonto the vessel in a smaller configuration and when deployed it isopened up to the correct size. The device opens the malleable stent bypulling open the docking legs that are located on the outside of thering-shaped body of the stent. The opening must match the adjoiningmalleable stent on the arterial side, if they are not the same size aleak will develop between the stents. The tool assures that the surgeonthe malleable ring of the stent is spread to the correct shape and size.Once the stent has been spread to the correct size, the compact firingtool will release the docking legs thereby releasing the malleablestent. The anvil will be released from the compact firing tool and thesurgeon will retrieve the anvil from the arteriotomy thereuponcompleting the firing operation.

[0335] As shown in FIG. 36B, the surgeon would choose the correctdisposable cassette to be loaded in the compact firing tool. Theproximal set would include aorta cassette 478 and proximal graftcassette 479. Attached to the proximal graft cassette are guide sutures400′ to be used in the docking procedure. The distal set includes arterycassette 452 and distal graft cassette 454 (see FIG. 36A). Attached todistal artery cassette 452 are guide sutures 400″. Each cassette willhave a receptacle end 480 that will be inserted into cassette port 480 a(see FIG. 29B) at the distal end of compact firing tool 450. Once thering-shaped malleable stent is installed onto compact firing tool 450,it is ready to be implanted into the patient. The anvil is placed intothe distal end of the compact firing tool. FIG. 29A shows that oncecassette 454 and the anvil are attached to the compact firing tool, itis ready to be placed in the graft vessel. The surgeon ties off the endof the graft vessel with a suture 481 and then makes an arteriotomy 482in the graft vessel. Anvil 460 of firing tool 450 is slid througharteriotomy 482 and positioned centrally within arteriotomy 482. Now thesurgeon is ready to fire compact firing tool 450 by placing his fingers483 around transverse finger grip 484 b on the proximal end of firingtool 450, and placing his thumb 485 through the thumb ring 486 a alsolocated on the proximal end of the firing tool.

[0336] Directly Loaded Firing Tool

[0337] A modified directly loaded compact firing tool 450′ and acartridge 466 for loading this tool are shown in FIGS. 31, 32A, 32B,33A, 33B and 33C. The tool 450′ corresponds to the tool 450, except thatit is constructed to have the stent loaded directly onto a supportplatform 462′ formed on the distal end of the tool, rather than tosupport the stent through means of a cassette. Elements of the tool 450′corresponding to those of the tool 450 are designated by like numerals,followed by a prime (′) sign, as follows: stem 456′; prong 458′; anvil460′; platform 462′; cutter assembly ring 463′; blades 464′; operatinghandle 470′; attaching groove 471′; stem lock 471 a′; stem receiver 471b′; slot 472 a′; distal end 474′; first transverse finger grip 484 a′;second transverse finger grip 484 b′; plunger 486′; thumb ring 486 a′;spreader bar carrier 630′; slot 630 a′; shoulder 631′; and spreader bar640′. All of these elements operate in generally the same way as thecorresponding elements of the tool 450; the only difference being thatno removable cassette and associated cassette release structure isprovided in the tool 450′. Anvil release remains the same.

[0338]FIGS. 32A and 32B show a disposable cartridge 466 for loading thering-shaped stents onto the platform 462′ of the compact firing tool450′. The cartridge holds the stent 476 for mounting onto the platformand shields the very long, sharp and fragile tines of the stent 476 fromany contact which would distort the tines from their proper form. Itcomprises a generally cylindrical body 467 having longitudinal slots 468which are proportioned for receipt of the spreader bars 640′ when thecartridge is used to place a stent on the tool 450′. Release levers 469are pivotally secured to opposite sides of the body 467 for movementbetween a closed condition supporting a stent 476 anvil therebetween(see FIG. 32B and FIGS. 33A and 33B) and an open condition (see FIG.33C) releasing the stent for support on the platform 462′. The opposedinterior surfaces of the levers 469 are formed with a annular groove 469a to support a stent therebetween when the levers are in the closedcondition (see FIG. 32B). In this condition, the levers also support thestem 456′ and anvil 460′. Tabs 469 b on the tops of the levers 469 holdthe anvil 460′ when the levers are in this closed condition. An elasticband 469 c extends around the levers 469 to normally bias the levers tothe closed condition. Finger grips 469 d are formed on the distal endsof the levers to enable the levers to be moved to the open conditionagainst the bias of the band.

[0339] It should be understood that the disposable cartridge 466 ispreloaded with the stent 476 prior to being delivered to the surgeon.Such preloading will be carried out in the course of manufacturing andpreparing the cartridge for use. An insertion jig (not illustrated) willbe used to place the stent in the cartridge during this process. Thecartridge will be delivered to the surgeon in a loaded sterilecondition.

[0340]FIG. 33A shows the disposable loading cartridge 466 as it is beingdirected into place over the distal end of the tool 450′. FIG. 33B showsthe cartridge fully engaged over the end of the tool with the stem 456′of the anvil engaged in the stem release lock 471 a′. FIG. 33Cillustrates the cartridge in the process of releasing the stent andanvil for support by the tool. In this process the finger grips 469 dare pinched together. Thereafter, while the levers are held in thepinched together condition, the cartridge is removed from the tool anddiscarded.

[0341]FIG. 37A is cross sectional view through the tip of disposablecassette 452 of the compact firing tool 450. Anvil 460 is located on theinside of vessel wall 489. Once the surgeon activates the compact firingtool by depressing his thumb on the plunger this activates driver 465which, via stem receiver 471 b, pushes malleable stent 476 forward indirection 491 against anvil 460. Malleable stent 476 is completelyconstrained and tines 492 are backed-up against platform 462 and aresupported by a shoulder 493 extending around the platform 462 so properturning of the fasteners is achieved without buckling. FIG. 37B shows anintermediate firing position. As driver 465 continues to move forward,tines 492 of malleable stent 476 are supported by platform 462 and areforced into matching pockets 488A in anvil 460. As tines 492 begin todeform and curl towards stem 494 of anvil 488, shoulder 493 maintainscontact with tines 492 thus preventing the tines from buckling outwardand folding over flat instead of being formed to curl in the anvilpocket. FIG. 37C shows the tine formation completed. Once tines 492 ofthe malleable stent have finished curling back through the vessel wall,cutter blades 464 is deployed incising a slit in the vessel wall insidethe malleable ring-shaped stent.

[0342] The final step in placing the malleable stent is spreading thestent open to a predetermined size. FIGS. 29B and 29C show the spreaderbar carrier 630 which is connected to the plunger 486 and thumb ring 486a. The surgeon will press plunger 486 with his thumb after the malleablestent is fully crimped. Once fully crimped, cutter blades 464 and thesecondary anvil are retracted.

[0343] Operation of the stent setting tool will be discussed withreference to FIGS. 31, 34A and 34B. A stent 600 includes a body 602 towhich fastener tines 604 are anchored and to which a tab 606 isanchored. Tab 606 corresponds to the tabs discussed above includingelements 74, 88, 100, 30C, 401, 405 and the like. Tab 606 includes legs608 each attached at one end thereof to body 602 and meeting at an apexsection 610 at a hole 612 which is defined through apex section 610 andan extension 614 extends from apex section 610. Two side notches 616 aredefined in the side edges of extension 614 and a notch 618 is defined inend edge 620 of extension 614. Tabs 606 are used to manipulate the stent602 for the purpose of adjusting the stent and permitting removal of theanvil as described above.

[0344] The tool shown in FIGS. 31, 34A and 34B includes a hollow body629 through which anvil stem 632 extends with anvil head 634 on one endthereof in position to be inserted through an incision into a vesselV_(X) as above described with concave guide grooves 636 in position toturn fasteners 604 inwardly toward edge 638 of the vessel adjacent tothe incision. A tissue cutter 639 is located adjacent to body 629 inposition to trim the vessel adjacent to the incision.

[0345] Pivotally attached to body 629 of the spreader bar carrier 630 isa spreader bar 640 for each tab 606. Each spreader bar 640 includes anarm 642 having one end pivotally attached to body 629 and a tab-engaginghead 644 on the other end. Arm 642 moves from a first position with head644 lying adjacent to body 629 to a second position with head 644 spacedfrom body 629, with the first position being indicated in solid lines inFIG. 35B and the second position being indicated in dotted lines in FIG.35B.

[0346] Head 644 includes two projections 646 which engage notches 616and is moved from the first position to the second position to spreadthe stent. A spreader sleeve 650 encircles body 629 and includes a camsurface 652 that slants upwardly and outwardly from body 629 adjacent tohead 644. Two spreader cam pins 654 are attached to head 644 andslidably engage cam surface 652 so that distalward movement of sleeve650 as indicated by arrow 656 forces the cam surface between pins 654and body 629 causing those pins to ride up surface 652 thereby forcinghead 644 outward in direction 658 toward the second position.

[0347] A stent retainer 660 is located between sleeve 650 and spreaderbar 640 and engages tab 606 at notch 618 to keep the tab attached tohead 644 whereby the outward movement of head 644 spreads stent 600.Distalward movement of body 629 in direction 656 forces fastener 604through the vessel and into the fastener guide of anvil 634 to form thefastener on the vessel as discussed above.

[0348] Once the stent is configured in the desired manner, the cutter639 can be operated and head 644 is disengaged from tab 606 by twistingthe tool.

[0349]FIGS. 34A and 34B show how the malleable stent is spread. When thesurgeon activates stretcher plunger 486, spreader sleeve 650 will movein the forward direction indicated by arrow 656. Spreader cam surface652 will make contact with spreader cam follower pin 654. Spreader camfollower pin 654 is attached to ring spreader arm 642 which pivots nearthe proximal end of the firing tool. When spreader cam surface 652 makescontact with spreader cam pin 654, ring spreader arm 642 will move awayfrom the center of the firing tool in direction 658 opening up malleablestent body 602 until the ring spreader bar bottoms out on the insidesurface of spreader sleeve 650. Docking tabs 606 will be ejected fromthe ring spreader bar thereby releasing the malleable stent body. FIG.29A shows the anvil release button CRB which the surgeon will press torelease the anvil. Now the surgeon will complete the procedure byremoving the anvil from the arteriotomy.

[0350] As discussed above, the fasteners of the stents may be formed bydriving them against an anvil head such as anvil head 274 shown in FIG.15 with a fastener turning section or groove 288 turning the fastenersinwardly from the position shown in FIG. 5 to the position shown in FIG.3, for example. However, as will be understood by those skilled in thesurgery art, the fasteners are very thin and must be correctly handledin order to ensure proper formation. If the fasteners are not properlyturned, they may simply crumple or fold instead of smoothly turning intothe FIG. 3 configuration.

[0351] Therefore, the present invention includes specially formedfastener tines such as shown in FIG. 51 as fastener tine 700. Fastenertine 700 is smoothly tapered from root 702 to tip 704 on both topsurface 706 and bottom surface 708, as well as on both side edges 710and 712. This multiplanar tapering causes the fastener tine to smoothlyturn from the FIG. 5 configuration to the FIG. 3 configuration as tip704 engages smoothly curving surface 714 (see FIG. 15) of anvil head274. As is also shown in FIG. 51, root 702 is concave and smoothlycurves at location 715 from top surface 716 of ring-shaped stent body718 to top surface 706 and at location 717 to bottom surface 708 offastener tine 700.

[0352] Fastener tine 700 is formed by a multiple etching process in themanner of a computer chip. Thus, a blank is masked and exposed to anetching solution in several steps to form the multiplanar fastener tine700. For the sake of description, fastener tine 700 is shown extendingradially outward from body 718 in FIG. 51. However, in use, the fastenertine will extend as shown in FIG. 15 or 62 A-B with respect to body 718.

[0353] More specifically, the manufacturing method in which themalleable stent will be fabricated is a chemical etch process. Thechemical etch process is capable of yielding a malleable stent withdifferent thickness as shown in FIG. 58A. Ring-shaped body 718 itselfmust be thicker than fastener tines 700. This will keep the body planarafter the spreading operation. If the body were too thin, it woulddistort into an uncontrollable shape. Fastener tines 700 must be thinnerthan ring-shaped body 718. This allows the tines to pierce the tissuewithout leaking and to form against the anvil. The process isillustrated in FIGS. 52-59. To begin the process, as shown in FIG. 52, asheet 720 of stainless steel is coated with a photoresist coating.Stainless steel, titanium or any other acceptable surgically implantablematerial can be used for the ring-shaped body. The photoresist coatingmay be applied by laminating, dip coating, spraying or any other meansknown to one skilled in the art. Since the photoresist coating is lightsensitive the coating should be carried out in a safe-light condition.After applying the photoresist to the metal sheet, the sheet is exposedto light with contact negatives 721 on the photoresist. This is done onboth sides of the sheet, so the mirror image of the malleable stent onthe bottom side is precision aligned to the malleable stent image on thetopside of the sheet. This creates the precise resist image required toproduce plurality of malleable ring-shaped stents 722 on both sides ofthe sheet as shown in FIG. 53. Alignment pins 723 or the like are usedto ensure precise alignment location between the top and bottomnegatives. This is done by first covering the coated sheet with anegative containing an image of the pattern of malleable stents. Nextthe sheet is placed under a light source rich in ultraviolet radiationto expose the photoresist coating on the sheet. After exposure, thephotoresist is rinsed in a developer to remove the unexposedphotoresist. Once the unexposed photoresist is fully removed, the sheetis baked to harden the remaining photoresist coating in the form ofmalleable stents. The sheet is now placed in a chemical bath that willetch away any areas that are not protected by the hardened photoresist.Once the sheet is rinsed removing the chemical etch bath, A single passchemical etch process yields a chisel point 724 as shown in FIG. 54.This chisel point 724 is not acceptable, since it will tend to cutthrough the tissue and allow relatively large pathways in which bloodleaks through the tine holes. The point that is needed to make aleak-free anastomosis is shown at 725 in FIG. 55A. It must taper inthree directions, a sharp point 726 and rounded edges 727. The processof producing an acceptable point will now be described. FIG. 56 showsthe body of the malleable stent being re-masked on both sides of the nowetched out stents with photoresist coating 728, except for tines 700.The sheet will go through the exposure, baking and rinsing operations asdescribed above and then back into the chemical etch bath. This time thesheet will be exposed to the chemical etch for a much shorter time. Theonly material that will be removed are the sharp edges on the tines.Once removed from the chemical etch bath for the second time, see FIG.55A, the new point configuration 726 with rounded edges 727 will bepresent.

[0354]FIG. 57 shows a partial view of finished sheet 720. Thering-shaped stents are held to the sheet with carrier tabs 729 placed atthe corners of each malleable stent. Also, registration holes 730 arelocated at the edges of the sheet. These holes are used to feed theunformed sheet 720 through a forming die in a controlled process to bendthe tines in the appropriate formation and remove malleable stents 731from the sheet. The sheet could be fed into an injection molding diewhere plastic will be formed around the stent in a configuration tofacilitate loading the stent into the compact firing tool or to surroundthe stent in an absorbable polymer as described below. Now the malleablestents are ready to be loaded into the disposable cartridge or cassette.Keeping the malleable stents in a discrete pattern allows the stents tobe formed, sheared and handled in an automated fashion.

[0355] In some instances, the desired spacing between tines causes oneor more of the tines to spatially coincide with a connection tab. Thissituation is illustrated in FIGS. 58B and 58C in which tine 700′coincides with a connection tab 732 having a guide hole 733 therein. Theetching process or any other process used to form the stent can bemodified, as will be understood by those skilled in the art based on theteaching of this disclosure, to physically place a tine, such as tine700′ on a tab such as tab 732.

[0356] A variation of the configuration for framework or stent 50 shownin FIG. 4A is shown in FIGS. 60-62 as framework 750. Framework 750includes a plurality of sections 752 to which fastener tines 753 areattached and sections 754 to which docking tabs are also attached.Bridge sections 756 are formed of absorbable material and connectsections 752 and 754 together. Framework 750 can be used with any of thedocking elements discussed above, and will at least partially absorbinto the patient's body after healing is complete. Sections 752 and 754are formed of non-absorbable surgical material, such as Titanium,Stainless Steel, or the like and remain in place. The individualnon-absorbable sections can move relative to each other whereby the sizeand shape of the opening can change based on the needs of the patient'sbody. The tines 753 are located on the non-absorbable sections.

[0357] Malleable framework 750 is formed with an over-molded absorbablepolymer. Malleable framework 750 would be manufactured in the samemanner as described above except the framework goes through a secondaryprocess of injection molding. The finished sheet is similar to the sheetshown in FIG. 57 except there are connector tabs 755 bridging betweentines 753. Unlike the malleable stent described above, the partiallyabsorbable malleable framework 750 is not-continuous. The bridgesections 756 provide discontinuities 758 where absorbable polymer isover-molded. The sheet is placed into an injection molding press usingregistration holes 730 shown in FIG. 57 to align the sheet. Once theabsorbable polymer is molded over the malleable stent connector tabs 755are sheared off in a die. This results in malleable ring sections 760held together with the absorbable polymer of the bridge section 756.FIG. 61 shows malleable stent 760 at the anastomosis of a graft 761 to acoronary artery 762 after a period of 6 weeks to 3 months. Theabsorbable polymer is no longer connected to malleable stent 760. Bythis time it has been absorbed into the body. This results in voids inthe malleable stent 760 at discontinuities 758, which allow theanastomosis to move and expand if there is an increased demand of bloodflow. The anastomosis elements can thus move to accommodate thepatient's tissue.

[0358] As discussed above, if the tines on the malleable ring-shapedstents are too far apart, leak paths may be formed; however, if thetines are too close together, the tissue may be damaged when the twovessels are coupled together. Accordingly, there is an optimum spacingof tines on the malleable mounting structure for a specified tissue. Forexample, a stent on the aorta will have different tine spacing andnumber of tines than a stent on a coronary artery. Therefore, theinventors have determined that the best mode of the malleablering-shaped stents will have tines spaced apart(centerline-to-centerline distance) of approximately 0.040 inches forend located tines, such as tines 800 shown in FIG. 62A and a spacing(centerline-to-centerline distance) of approximately 0.030 inches forside located tines, such as tines 801 of FIG. 62A. A tolerance ofapproximately ±0.003 inches can be accepted to account for tinemisalignment while still providing proper tissue compression and aleak-free joint in the best mode. As shown in FIG. 63, positive peak tonegative peak spacing (P1 to P2 spacing in FIG. 27) of 0.015 inches isused in the best mode as is a tine thickness adjacent to the ring bodyof approximately 0.005 inches. The misalignment illustrated in FIG. 63is acceptable.

[0359] It is understood that while certain forms of the presentinvention have been illustrated and described herein, it is not to belimited to the specific forms or arrangements of parts described andshown. For example, docking elements other than those disclosed abovecan be used without departing from the scope of the present disclosure.Examples of such alternative docking elements include Tinnerman fastenertype elements, C-clips, clips with VELCRO, elastomeric clips, adhesiveand the like. Still other docking methods contemplated by this inventioninclude elastomeric rings, folding or twisting one docking leg overanother docking leg, folding both docking legs together, twisting bothdocking legs together, crimping both docking legs together, having apost on one docking leg penetrate a hole on the mating docking leg,having a post with a retention feature on one docking leg penetrate ahole on the mating docking leg, having a post on one docking legpenetrate a hole with a retention feature on the mating docking leg, asuture loop to hold the docking legs together, a c-shaped clip that iscrimped over the docking legs, a spring-loaded c-shaped clip that holdsthe docking legs together, a spring-loaded c-shaped clip with anintegral suture cutter, magnetic docking legs that align and hold thedocking legs together, a rubber collar with a steel ring that binds onthe guide suture which holds the docking legs together, and the dockinglegs are bonded together with a rivet. Still further, the inventors havediscovered and as will be understood from the above teaching, the methodby which the stents are docked or joined, influences joint compression.Since docking is a function of a number of factors, these factorsinclude the joining medium or the spring rate of the joining legs sothat by varying these two factors a compliant joint can be constructedwhich provides a joint that is just tight enough to seal but not tightenough to crush the tissue. Yet another factor that can be varied is thewidth of the ring-shaped stent so that by increasing or decreasing thelength of the docking legs the joint can be made more or less compliant.For example by decreasing the width of a docking leg, the joint can bemade more flexible for thicker tissue. Another factor is the shape ofthe tines. A thicker tine will hold the malleable stent better on tissuethat has less tensile strength, such as aorta. A thinner tine will workbetter on small arteries less than 2 millimeters. FIGS. 64A and 64Billustrate yet another alternative form of the malleable ring-shapedstent with manufacturing dimensions thereon.

We claim:
 1. An anastomotic device comprising: A) a first malleablemounting structure for mounting on a first vessel; B) a second malleablemounting structure for mounting on a second vessel; C) a coupling forconnecting said first mounting structure to said second mountingstructure; and D) first and second fasteners for attaching said firstand second malleable mounting structures to the first and secondvessels, respectively, adjacent to incisions in the first and secondvessels to position an inside surface of the first vessel adjacent tothe incision in the first vessel in abutting contact with an insidesurface of the second vessel adjacent to the incision in the secondvessel to form a joint establishing sealed interior communicationbetween the first and second vessels.
 2. The anastomotic device definedin claim 1 wherein the joint is of a generally sinusoidal shape.
 3. Theanastomotic device defined in claim 2 wherein said generally sinusoidalshape includes a positive lobe and a negative lobe located adjacent toeach other.
 4. The anastomotic device defined in claim 3 wherein thefirst fastener is positioned to form a positive lobe when said joint isformed and the second fastener is positioned to form a negative lobewhen said joint is formed.
 5. The anastomotic device defined in claim 1wherein a plurality of first and second fasteners are provided and eachfirst fastener is interdigitated with an adjacent second fastener. 6.The anastomotic device defined in claim 1 wherein each of said first andsecond malleable mounting structures includes an inside edge and anoutside edge with the inside edges being located adjacent to theincision in the respective vessel and interiorly of the outside edgeswhen the structures are mounted on a vessel, said first and secondfasteners being located adjacent to the outside edges.
 7. Theanastomotic device defined in claim 1 wherein the fasteners forattaching the mounting structures are located on each mounting structureand spaced apart from each other by different spacings according towhether the vessel on which the mounting structure is to be mounted isan aorta or a coronary artery.
 8. The anastomotic device defined inclaim 1 further comprising means for varying the stiffness of the joint.9. The anastomotic device defined in claim 1 wherein each fastenerincludes a body having a root attached to an associated malleablemounting structure and a tip spaced from the associated malleablemounting structure, said body further including a top surface, a bottomsurface and edges.
 10. The anastomotic device defined in claim 9 whereinsaid top and bottom surfaces taper toward each other from said root tosaid tip.
 11. The anastomotic device defined in claim 10 wherein saidedges taper toward each other from said root to said tip.
 12. Theanastomotic device defined in claim 1 wherein the coupling comprises atab on each malleable mounting structure.
 13. The anastomotic devicedefined in claim 12 wherein the coupling further comprises a maleelement on one tab and a female element on another tab.
 14. Theanastomotic device defined in claim 1 further comprising guide structurefor guiding said first and second malleable mounting structures intoalignment with each other.
 15. The anastomotic device defined in claim14 wherein the guide structure comprises an elongate tensile memberextending from one of said first and second malleable mountingstructures to the other malleable mounting structure.
 16. Theanastomotic device defined in claim 15 wherein the other malleablemounting structure is connected for movement along said elongate tensilemember.
 17. The anastomotic device defined in claim 15 wherein saidelongate tensile member is attached to one of said first and secondmalleable mounting structures.
 18. The anastomotic device defined inclaim 17 wherein the coupling comprises a clamp and said clamp includesa cutting means for cutting said elongate tensile member.
 19. Theanastomotic device defined in claim 15 further compromising a securingstructure for holding one of said first and second malleable mountingstructures to said elongate tensile member.
 20. The anastomotic devicedefined in claim 12 wherein said coupling comprises means for forming asnap fit between said first and second malleable mounting structures.21. The anastomotic device defined in claim 1 wherein each malleablemounting structure comprises a portion that is formed of material thatis absorbed into a patient's body after a healing process.
 22. Theanastomotic device defined in claim 1 further comprising a tool formanipulating each malleable mounting structure into contact with thevessels and manipulating the mounting structures after the structureshave been engaged with the vessels.
 23. The anastomotic device definedin claim 1 wherein said coupling comprises docking elements of eachmalleable mounting structure and an elastomeric ring engageable aroundthe docking elements to couple the mounting structures together.
 24. Theanastomotic device defined in claim 1 wherein said coupling comprises afoldable element on one mounting structure and an element on the othermounting structure about which said foldable element may be folded tocouple said mounting structures together.
 25. The anastomotic devicedefined in claim 1 wherein said coupling comprises a docking element oneach mounting structure, said docking elements being twisted together tocouple said mounting structures together.
 26. The anastomotic devicedefined in claim 1 wherein said coupling comprises a pre-tied elongatetensile member attached to a docking element on one malleable mountingstructure and a clamp carried by said tensile member for engagement withthe other mounting structures.
 27. The anastomotic device defined inclaim 1 wherein said coupling comprises a magnetized docking element onone of said malleable mounting structures for magnetic attraction of adocking element on the other of the structures.
 28. The anastomoticdevice defined in claim 1 wherein said coupling comprises a rivetengageable with the first and second mounting structures.
 29. Ananastomosis joint comprising: A) a first vessel having an incisiondefined therein and an edge adjacent to said incision; B) a secondvessel having an incision defined therein and an edge adjacent to theincision in the second vessel; and C) mounting structure secured to thefirst and second vessels, said structure placing said first vessel incontact with said second vessel with an inside surface of the firstvessel adjacent to the incision in the first vessel in abutting contactwith an inside surface of the second vessel adjacent to the incision inthe second vessel to form a joint establishing sealed interiorcommunication between the first and second vessels.
 30. The anastomosisjoint defined in claim 29 wherein the joint is of a generally sinusoidalshape.
 31. The anastomosis joint of claim 29 wherein the inside surfacesof the first and second vessels in abutting contact are edge surfaces ofthe incisions in the vessels.
 32. The anastomosis joint defined in claim29 further comprising first fasteners securing the mounting structure tothe first vessel and second fasteners securing the mounting structure tothe second vessel, said first fasteners being interdigitated withadjacent second fasteners when said joint is formed.
 33. The anastomosisjoint defined in claim 32 further comprising a first fastener mountingelement on the first vessel having a body with an inside edge locatedadjacent to the incision in the first vessel and an outside edge locatedso the body of the first fastener mounting element is positioned betweenthe inside edge and the outside edge of the first fastener mountingelement, and a second fastener mounting element on the second vesselhaving a body with an inside edge located adjacent to the incision inthe second vessel and an outside edge located so the body of the secondfastener mounting element is positioned between the inside and theoutside edges of the second fastener mounting element, said fastenersbeing mounted on said fastener mounting elements adjacent to the outsideedges of the fastener mounting elements.
 34. A method for performing ananastomosis comprising: A) defining an incision in a first vessel; B)defining an incision in a second vessel; C) mounting a first malleablemounting structure on the first vessel adjacent to the incision in thefirst vessel; D) mounting a second malleable mounting structure on thesecond vessel adjacent to the incision in the second vessel; E) guidingthe first malleable mounting structure and the second malleable mountingstructure into contact with each other; F) placing the first and secondvessels against each other to form an area of in abutting contacttherebetween adjacent to the first and second malleable mountingstructures; and G) forming the area of abutting contact between thevessels into a generally sinusoidal shape.
 35. The method defined inclaim 34 wherein the step of guiding the first malleable mountingstructure and the second malleable mounting structure into contact witheach other includes interdigitating portions of the first malleablemounting structure and portions of the second-malleable mountingstructure.
 36. The method defined in claim 34 wherein in the step ofguiding the first malleable mounting structure and the second malleablemounting structure into contact with each other includes extending anelongate tensile member between the mounting structures and guiding oneof the mounting structure along the tensile member.
 37. The methoddefined in claim 34 wherein the step of guiding the first malleablemounting structure and the second malleable mounting structure intocontact with each other includes clamping the first and second malleablemounting structures together.
 38. The method defined in claim 36 whereinthe step of guiding the first malleable mounting structure and thesecond malleable mounting structure into contact with each other furtherincludes threading the tensile member through a portion of one of themounting structures.
 39. The method defined in claim 37 wherein thefirst and second malleable structures are clamped together after thestructures contact and the step of guiding the first malleable mountingstructure and the second malleable mounting structure into contact witheach other further comprises cutting the tensile member after themounting structures are clamped together.
 40. A method for forming ananastomosis comprising: A) forming an incision in a first vessel; B)installing an anvil into the first vessel through the incision; C)mounting a first malleable mounting structure on the first vessel bysetting fasteners on the first mounting structure into the first vesseladjacent to the incision; D) fully forming the fasteners by driving themagainst the anvil and gently turning them toward the incision; E)manipulating the first mounting structure into a configuration openingthe incision in the first vessel; F) removing the anvil from the firstvessel through the incision therein; G) forming an incision in a secondvessel; H) installing an anvil into the second vessel through theincision in the second vessel; I) mounting a second malleable mountingstructure on the second vessel by setting fasteners on the secondmounting structure into the second vessel adjacent to the incision inthe second vessel; J) fully forming the fasteners of the second mountingstructure by driving them against the anvil in the second vessel andgently turning them toward the incision in the second vessel; K)manipulating the second mounting structure into a configuration openingthe incision in the second vessel; L) removing the anvil from the secondvessel through the incision therein; M) guiding the first and secondmounting structures into contact with each other to bring the first andsecond vessels in abutting contact with each other; and N) connectingthe first and second mounting structures together.
 41. The methodaccording to claim 40 further comprising trimming the first and secondvessels adjacent the incisions formed therein.
 42. The method accordingto claim 40 wherein, upon guiding of the first and second mountingstructures into contact, the fasteners on the respective structuresinterdigitate with each other and the vessels contact to form agenerally sinusoidal joint therebetween.
 43. A process for forming amalleable anastomosis stent comprising: masking both sides of a sheet ofmalleable material using a photo negative mask in a pattern of an entirestent; immersing the sheet in a chemical bath; re-masking both sides ofthe sheet with a photo negative mask around a body portion of the stentbeing formed, except for tine areas associated with the stent;re-immersing the sheet into the chemical bath; removing the sheet fromthe chemical bath; passing the removed sheet through a progressive dieto form tines on the stent; and removing the stent from the sheet. 44.The process defined in claim 43 further comprising a step of etching thesheet and creating registration features on the sheet.
 45. The processdefined in claim 43 wherein the formed stent has a body and tines on thebody, with the tines being thinner than the body.
 46. The processdefined in claim 43 further comprising immersing the sheet into achemical bath to clean it.
 47. The process defined in claim 46 furthercompromising coating both sides of the sheet with photoresist.
 48. Theprocess defined in claim 47 further comprising applying a negative maskto both sides of the sheet and forming mirror images of the stent onboth sides of the sheet.
 49. The process defined in claim 48 furthercomprising aligning the negative mask on one side of the sheet with thenegative mask on the other side of the sheet with registration features.50. The process defined in claim 49 further comprising placing the sheetunder a source of UV rich light on both sides after the negative masksare aligned.
 51. The process defined in claim 50 further comprisingremoving the negative masks and immersing the sheet in a developer andhardening the areas that were exposed to light.
 52. The process definedin claim 51 further comprising washing the sheet free of developer andnon-hardening photoresist.
 53. The process defined in claim 52 furthercomprising placing the light-exposed sheet into a chemical bath andetching away areas of the sheet not protected by hardened photoresist.54. The process defined in claim 53 further comprising removing thesheet from the chemical bath and washing away chemical etchant andstripping the remaining photoresist with a solvent.
 55. The processdefined in claim 54 further comprising tapering each tine in twodirections to leave a sharp pointed tip on the tines with smooth edges.56. The process defined in claim 55 further comprising coating bothsides of the remaining sheet with photoresist.
 57. The process definedin claim 56 further comprising applying a negative mask to both sides ofthe sheet only on the body portion of the stent and forming a mirrorimage of the stent on both sides of the sheet.
 58. The process definedin claim 57 further comprising aligning the negative mask on one side ofthe sheet with the negative mask on the other side of the sheet usingregistration features.
 59. The process defined in claim 58 furthercomprising placing the sheet under a source of UV rich light on bothsides after the negative masks are aligned.
 60. The process defined inclaim 59 further comprising removing the negative masks and immersingthe sheet in a developer and hardening the areas that were exposed tolight.
 61. The process defined in claim 60 further comprising washingthe sheet free of developer and non-hardened photoresist.
 62. Theprocess defined in claim 61 further comprising placing the sheet into achemical bath and etching away tine areas that are not protected byhardened photoresist.
 63. The process defined in claim 62 furthercomprising removing the sheet from the chemical bath and washing awaychemical etchant and stripping the remaining photoresist with solvent.64. An anastomosis stent formed by a process which comprises: providinga chemical double etch process which includes using a photo negativemask and forming a pattern of an anastomosis stent on a sheet ofmaterial; immersing the sheet in a chemical bath; re-masking the sheetwith a photo negative around the pattern of an anastomosis stent exceptfor tine areas associated with the stent; re-immersing the sheet intothe-chemical bath; removing the sheet from the chemical bath; passingthe removed sheet through a progressive die; and removing the stent fromthe sheet.
 65. An anastomosis joint comprising: a first malleablemounting structure mounted on a first vessel; a second malleablemounting structure mounted on a second vessel; and means for joiningsaid first and second malleable mounting structures and forming tissueassociated with the first and second vessels adjacent to said first andsecond malleable mounting structures into a complimental shape forjoinder.
 66. The anastomosis joint defined in claim 65 wherein saidshape is generally sinusoidal.
 67. The anastomosis joint defined inclaim 65 further comprising means for adjusting stiffness of ananastomosis joint formed when said first and second malleable mountingstructures are joined with tissue therebetween.
 68. The anastomosisjoint defined in claim 67 wherein said means for adjusting stiffnesscomprises a body of one of said malleable mounting structures.
 69. Theanastomosis joint defined in claim 67 wherein said malleable mountingstructures include deformable bodies and said means for adjustingstiffness comprises docking legs attached to said bodies.
 70. Theanastomosis joint defined in claim 65 wherein the means is adapted toform the tissue into a compliant joint.
 71. A guide tool for use inperforming an anastomosis comprising: a handle; a hand grip on one endof said handle; a nest on another end of said handle, said nest beingsized and shaped to receive a malleable mounting structure and includingleg retention members which releasably engage docking legs on amalleable mounting structure received within the nest; and meansoperably connecting said hand grip to said nest to release the mountingstructure from said nest.
 72. An installing tool for installing amalleable mounting structure on a vessel for use in performing ananastomosis comprising: a handle; a hand grip on one end of said handle;a cassette accommodating receiver on another end of said handle; and alock for securing a cassette to the receiver, said lock beingselectively operable to release the cassette.
 73. The installing tooldefined in claim 72 further comprising a malleable mounting structurereleasably mounted in said cassette.
 74. The installing tool defined inclaim 73 wherein said malleable mounting structure includes tines forpenetrating the vessel and the tool further comprises an anvil on saidcassette for selectively crimping the tines to secure the mountingstructure to the vessel.
 75. The installing tool defined in claim 72further comprising a cassette secured to the receiver and including amalleable mounting structure in said cassette, said mounting structureincluding tines for attaching said mounting structure to a patient'stissue.
 76. The installing tool defined in claim 75 further comprisingmeans in said cassette for protecting said tines.
 77. The installingtool defined in claim 75 further comprising means on said cassette forsupporting said tines as said mounting structure is being attached tothe vessel.
 78. The installing tool defined in claim 75 furthercomprising means on said handle for deforming the mounting structureinto a desired shape and size.
 79. A disposable cassette for use inperforming an anastomosis comprising: a body; means on said body formounting a malleable mounting structure on said body; and means carriedby said body for releasably attaching said body to an installing tool.80. The disposable cassette defined in claim 79 wherein the means forreleasably attaching said body to an installing tool includes an anvilhaving a stem extending through the body and a prong on said stem havinga groove engageable by a releasable locking element.
 81. An installingtool for installing a malleable mounting structure on a vessel for usein performing an anastomosis comprising: a handle; a hand grip on oneend of said handle; means for releasably attaching a malleable mountingstructure on said handle; and means on said handle for manipulating amalleable mounting structure attached to said handle to malleablyconfigure the mounting structure.
 82. The installing tool defined inclaim 81 wherein a malleable mounting structure includes tines forpenetrating the vessel and the tool further comprises an anvil on saidhandle for selectively crimping the tines to secure the mountingstructure to the vessel.
 83. The installing tool defined in claim 82further comprising a knife on said handle for enlarging an incision inthe vessel.
 84. A tool for use in performing an anastomosis comprising:A) a flexible outer shaft; B) an operating handle on one end of saidouter shaft; C) a flexible core shaft slidably located in said outershaft; D) an O-ring slidably mounted on a distal end of said core shaft;E) a countersink tip on said core shaft distal end for engagement withdocking elements of two malleable mounting structures; and F) saidoperating handle being connected to said flexible core shaft to movesaid core shaft with respect to said outer shaft to force said O-ringoff of said core shaft and onto docking elements engaged with said tipto attach the docking elements together.
 85. A device for use in formingan anastomosis said device being comprised of a first malleable mountingstructure comprising: A) a plurality of non-absorbable sections formedof material that is not absorbed by a patient's tissue; B) a pluralityof absorbable sections connecting said non-absorbable sections togetherand formed of material that is absorbable by the patients tissue; and C)fasteners on said non-absorbable sections for attaching saidnon-absorbable sections to the patient's tissue.
 86. The device definedin claim 85, wherein the first mounting structure further comprises adocking element on one of said non-absorbable sections.
 87. The devicedefined in claim 86 further being comprised of a second malleablemounting structure cooperable with the first structure to form ananastomotic joint.
 88. The device defined in claim 87 further comprisinga docking element on said second malleable mounting structure.
 89. Thedevice defined in claim 87 wherein said second malleable mountingstructure further comprises a plurality of non-absorbable sections and aplurality of absorbable sections connecting the non-absorbable sectionsof said second mounting structure together.
 90. The device defined inclaim 89 further comprising fasteners on the non-absorbable sections ofsaid second mounting structure for attaching said second mountingstructure to the patient.
 91. The device defined in claim 90 wherein thefasteners on the first and second mounting structures are oriented withrespect to each other so the fasteners of said first and second mountingstructures are interdigitated with each other to capture the patient'stissue therebetween and form a joint having a generally sinusoidalshape.
 92. The device defined in claim 89 wherein said non-absorbablesections are formed of Titanium.
 93. The device defined in claim 89wherein said non-absorbable sections are formed of stainless steel. 94.An anastomosis joint comprising: A) a first mounting structure mountedon a first vessel of a patient, said first structure being comprised ofa plurality of unconnected elements each having a fastener attaching theelement to the first vessel; B) a second mounting structure on a secondvessel of the patient, said second structure being comprised of aplurality of unconnected elements each having a fastener attaching theelement to the second vessel; C) docking elements on each mountingstructure; and D) coupling elements connecting the docking elements ofsaid first and second mounting structures together.
 95. The anastomosisjoint defined in claim 94 wherein the fasteners of the first mountingstructure interdigitate with the fasteners of the second mountingstructure to force tissue of the vessels adjacent the fasteners into agenerally sinusoidal shape.
 96. An anastomosis joint comprising: A) afirst mounting structure mounted on a first vessel of a patient, saidstructure being comprised of a plurality of non-absorbable elements eachhaving a fastener attaching the element to the first vessel; B) aplurality of absorbable elements connecting the non-absorbable elementsof the first mounting structure together; C) a second mounting structureon a second vessel of the patient, said structure being comprised by aplurality of non-absorbable elements each having a fastener attachingthe element to the second vessel; D) a plurality of absorbable elementsconnecting the non-absorbable elements of the second mounting structuretogether; E) docking elements on each mounting structure; and F)coupling elements connecting the docking elements of said first andsecond mounting structures together.
 97. The anastomosis joint claim 96wherein the fasteners of the first mounting structure interdigitate withthe fasteners of the second mounting structure to force tissue of thevessels adjacent the fasteners into a generally sinusoidal shape. 98.The anastomosis joint defined in claim 94 wherein each of saidunconnected elements is formed of Titanium.
 99. The anastomosis jointdefined in claim 94 wherein each of said unconnected elements is formedof Stainless Steel.
 100. The anastomosis joint defined in claim 96wherein each of the non-absorbable elements is formed of Titanium. 101.The anastomosis joint defined in claim 96 wherein each of thenon-absorbable elements is formed of Stainless Steel.
 102. A tool forsecuring tines extending from a malleable ring-shaped anastomotic stentto body tissue, said tool comprising: A) an elongate body having asurface at one end thereof for supporting the stent in a condition wherethe tines extend from said one end; B) an anvil carried by and mountedfor movement relative to the body towards and away from the tines of astent supported on said surface; and C) an operator to selectively movethe anvil towards said surface to crimp the tines of a stent supportedon said surface.
 103. The tool defined in claim 102 wherein the anvilhas a stem extending therefrom towards the body.
 104. The tool definedin claim 103 wherein the operator comprises: A) an elongate shaftextending through the body for longitudinal movement relative thereto;and B) a connector between one end of the shaft and the stem, saidconnector being selectively releasable to permit the anvil to bedetached from the body after the tines of a stent supported by the bodyhave been crimped.
 105. The tool defined in claim 104 further comprisinga handle secured to the shaft for movement therewith relative to thebody to pull the anvil towards the support surface.
 106. The tooldefined in claim 102 further comprising spreader bars carried by thebody for engagement with a stent supported on said surface, said barsbeing selectively operable to shape the stent.
 107. The tool defined inclaim 106, further comprising: A) a spreader bar carrier mounted on thebody for longitudinal movement relative thereto, said spreader barsbeing secured to the carrier for movement therewith; and B) mutuallyengagable cam surfaces on the spreader bars and body to move thespreader bars laterally relative to the body in response to longitudinalmovement of the carrier relative to the body.
 108. The tool defined inclaim 106 wherein said spreader bars are operable after the stent hasbeen secured to body tissue to manipulate the tissue.
 109. The tooldefined in claim 102 further comprising a tissue cutter carried by thebody, said cutter being selectively extensible relative to said surfaceto create a predetermined cut in tissue to which a stent supported onthe surface has been secured.
 110. The tool defined in claim 109 whereinthe operator and the cutter are mutually engagable to extend the cutterrelative to said surface upon full crimping of the tines by the anvil inresponse to actuation of the operator.
 111. A tool for securing tinesextending from a malleable ring-shaped anastomotic stent to body tissue,said tool comprising: A) an elongate body having a cassette pocket atone end thereof removably receiving a stent carrying cassette, saidcassette having an end surface supporting a the stent in a conditionwhere the tines extend from said one end; B) an anvil carried by saidcassette and mounted for movement relative to the body towards and awayfrom the tines of the stent supported on said surface; and C) anoperator carried by the body and secured to the anvil to selectivelymove the anvil towards said surface to crimp the tines of a stentsupported on said surface.
 112. The tool defined in claim 111 whereinthe anvil is supported on a stem carried by and extending from thecassette.
 113. The tool defined in claim 112 wherein the operatorcomprises: A) an elongate shaft extending through the body forlongitudinal movement relative thereto; and B) a connector between oneend of the shaft and the stem, said connector being selectivelyreleasable to permit the anvil to be detached from the cassette afterthe tines of a stent supported by the cassette have been crimped. 114.The tool defined in claim 113 further comprising a handle secured to theshaft for movement therewith relative to the body to enable the anvil tobe pulled toward the support surface.
 115. The tool defined in claim 111further comprising spreader bars carried by the body for engagement witha stent supported on said cassette, said bars being selectively operableto shape the stent.
 116. The tool defined in claim 115, furthercomprising: A) a spreader bar carrier mounted on the body forlongitudinal movement relative thereto, said spreader bars being securedto the carrier for movement therewith; and B) mutually engagable camsurfaces on the spreader bars and body to move the spreader barslaterally relative to the body in response to longitudinal movement ofthe carrier relative to the body.
 117. The tool defined in claim 115wherein said spreader bars are operable after the stent has been securedto body tissue to manipulate the tissue.
 118. The tool defined in claim111 further comprising a tissue cutter carried by the cassette, saidcutter being selectively extensible relative to said surface to create apredetermined cut in tissue to which a stent supported on the cassettehas been secured.
 119. The tool defined in claim 118 wherein theoperator and the cutter are mutually engagable to extend the cutterrelative to the cassette upon full crimping of the tines by the anvil inresponse to actuation of the operator.
 120. A cassette for supportingmalleable ring-shaped anastomotic stent having tines extendingtherefrom, said cassette comprising: A) a body having a surface at oneend thereof for supporting the stent in a condition where the tinesextend from said one end; and B) an anvil carried by and mounted formovement relative to the body towards and away from the tines of a stentsupported on said surface.
 121. The cassette defined in claim 120wherein the anvil is supported on a stem carried by and extending fromthe body for movement relative thereto.
 122. The cassette defined inclaim 120 further comprising a tissue cutter carried by the body, saidcutter being selectively extensible relative to said surface to create apredetermined cut in tissue to which a stent supported on the surfacehas been secured.
 123. The cassette defined in claim 121 furthercomprising a tissue cutter carried by the body, said cutter beingslidably received on the stem and selectively extensible relative tosaid surface to create a predetermined cut in tissue to which a stentsupported on the surface has been secured.
 124. A loading cartridge forshielding a ring-shaped malleable stent having delicate fastening tinesextending therefrom and depositing the stent on a supporting platformwith the times extending away from the platform, said cartridgecomprising: A) a body having an open end proportioned for engagementover the platform; and B) stent supporting elements carried by the bodyfor movement relative thereto between a first condition supporting themalleable stent within the open end of the body and a second conditionreleasing the stent for deposit on the supporting platform.
 125. Theloading cartridge defined in claim 124 further comprising a resilientmember normally biasing the stent supporting elements to the firstcondition.
 126. The loading cartridge defined in claim 125, furthercomprising grips on said supporting elements to enable force to beapplied thereto to selectively move the elements between the first andsecond conditions.
 127. The loading cartridge defined in claim 124further comprising anvil supporting elements on the stent supportingelements, said anvil supporting elements being adapted to carry an anvilin spaced relationship to the tines of the stent carried by thecartridge and deposit the anvil with the stent upon movement of thestent supporting elements to the second condition.
 128. The loadingcartridge defined in claim 127 wherein the anvil supporting elements arespaced to accommodate a stem secured to the anvil in a condition wherethe stem extends through a stent supported by the stent supportingelements.
 129. A method for preparing a vessel for anastomosis, saidmethod comprising: A) forming an incision in the vessel; B) installingan anvil into the vessel through the incision; C) mounting a malleablemounting structure on the vessel by setting fasteners on the mountingstructure into the vessel adjacent the incision; D) securing themounting structure to the vessel by driving the fasteners against theanvil to crimp the fasteners into the vessel; E) manipulating themounting structure into a configuration opening the incision; and F)removing the anvil from the vessel through the incision.